BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBE
Report
- Report Number
- 1917413-2023-00191
- Event Type
- Malfunction
- Date Received
- March 15, 2023
- Date of Event
- February 20, 2023
- Report Date
- May 11, 2023
- Manufacturer
- BECTON, DICKINSON & CO. (BROKEN BOW)
- Product Code
- JKA
- UDI-DI
- 50382903678612
- PMA / PMN Number
- BK050036
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2200108 MEDICAL DEVICE EXPIRATION DATE: 2023-11-30 DEVICE MANUFACTURE DATE: 2022-07-19 MEDICAL DEVICE LOT #: UNKNOWN MEDICAL DEVICE EXPIRATION DATE: UNKNOWN DEVICE MANUFACTURE DATE: UNKNOWN A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED WITH ADDITIONAL INFORMATION: B5. IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBE THE STOPPER POPS OUT OF THE TUBE AND THERE IS SAMPLE LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE PURPLE CAPS TUBES SITUATION IN DETERMINED BATCHES, AFTER THEY ARE DECAPPED, THE STOPPERS POP OFF BY THEMSELVES AND THE SAMPLES ARE CONTINUOUSLY SPILLED, LEADING TO CONTAMINATION OF THE EQUIPMENT, HIGH BIOLOGICAL RISK, NEW SAMPLE ACQUISITION, AND DELAY IN RESULTS FOR CRITICAL PATIENTS, WHICH IS WHY IT'S EXTREMELY PRIORITIZED TO BE VERIFIED. STOPPER POP OFF FOR EDTA TUBE BATCH 2200108." ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON 13.MAR.2023: 1)BELOW IT IS REPORTED THAT THERE WAS CONTACT OF THE PATIENT'S BLOOD/BIOLOGICAL FLUIDS WITH THE PROFESSIONAL'S MUCOUS MEMBRANES (WHICH ARE EYES, MOUTH, NOSE). COULD YOU PLEASE CONFIRM THAT INFORMATION? WAS THERE THAT EXPOSURE? A: THERE WAS NO EXPOSURE AT THE MUCOSAL LEVEL, ONLY CONTACT WITH (GLOVED) HANDS. 2) IF SO, DID THE PROFESSIONALS DO ANY TESTS? DID THEY TAKE ANY PROPHYLACTIC MEDICATION? A: NOT APPLICABLE. ADDITIONAL INFORMATION RECEIVED ON 13.MAR.2023: ¿ HOW MANY UNITS OF THE PRODUCT PRESENTED THE REPORTED DEVIATION? (AMOUNT AFFECTED / NUMBER OF EVENTS / SAMPLES AFFECTED); A: 11 UNITS IN THE LAST REVIEW CARRIED OUT (1 NIGHT SHIFT). ¿ IT MENTIONS ¿CERTAIN LOTS¿. WAS THE REPORTED INCIDENT NOTED ONLY IN LOT 2200108 OR WERE THERE OTHERS? IF THERE WERE OTHERS, PLEASE REPORT THE LOTS AFFECTED: A: LOT 2200108. ¿ WHAT IS THE OTHER PREVIOUS REFERENCE WHICH WOULD HAVE THE MOST CONTROLLED SITUATION? HAVE YOU REPORTED IT TO BD? PLEASE, INFORM BATCH AND CATALOG OF THE OTHER PRODUCTS THAT HAVE PRESENTED THE DEVIATION: A: EXECUTIVE SALES INFORMS THAT THAT REFERENCE HAS BEEN DISCONTINUED. (CHECK WITH HIM). ¿ HAS THERE BEEN EXPOSURE OF BLOOD FROM PATIENTS TO THE MUCOUS MEMBRANES OR SKIN OF PROFESSIONALS DUE TO EQUIPMENT CONTAMINATION AND BIOLOGICAL RISK? (DETAIL) A: YES THERE HAS BEEN. ¿ IF YES, PLEASE DESCRIBE THE POST-EXPOSURE PROPHYLACTIC ACTIONS TAKEN: A: CLEANING AND DISINFECTION. ¿ WAS THERE AN IMPACT DUE TO THE DELAYS IN THE RESULTS FOR CRITICALLY ILL PATIENTS? EG: DEATH, DAMAGE, CHANGE OF TREATMENT, DIAGNOSTIC ERROR, ETC.; A: DELAYS IN RESULTS, REDO SAMPLING, NON-QUALITY COSTS DUE TO REPROCESSING. ¿ PLEASE DESCRIBE THE IMPACT AND ACTIONS TAKEN BECAUSE OF IT: R: IMPACT ON PATIENT IN DELAYS AND RE-PUNCTURE, DISSATISFACTION, ACTION: TUBE VERIFICATION WITH ANOTHER PROVIDER. ¿ WHEN DO THE LIDS PUSH "BY THEMSELVES"? (EG: IN THE ANALYSIS EQUIPMENT, DURING CENTRIFUGATION, DURING TRANSPORT, ETC.); A: WHEN THEY ARE RESTING ON THE RACK, STAY STILL. ¿ WAS A SYRINGE USED TO DRAW BLOOD FROM THE OPEN SYSTEM AND THEN FILL THE TUBES? IF YES, WAS THE PLUNGER PUSHED INTO THE BLOOD? A: A SYRINGE WITHOUT A NEEDLE POINTED AT THE ARTERIAL LINE WAS USED TO TAKE THE SAMPLE, AS HAS ALWAYS BEEN DONE. ¿ DOES THE DIVERSION OCCUR ONLY WITH THE TUBES THAT WILL BE USED FOR INTAKE BY OPEN SYSTEM? A: IT IS NOT EASY TO IDENTIFY. ¿ IF DRIFT ALSO OCCURS WITH CLOSED INTAKE TUBES, WHAT ACQUISITION DEVICE WAS USED? WAS IT FROM BD? A: N/A ¿ IF THE DRIFT ALSO OCCURS WITH CLOSED INTAKE TUBES, WAS A HOLDER USED? WAS IT THE BD HOLDER? A: N/A ¿ COULD YOU SEND PHOTOS AND/OR VIDEOS SO THAT IT IS POSSIBLE TO OBSERVE THE REPORTED DEVIATION? A: THEY WERE SENT TO THE SALES EXECUTIVE. ¿ WHEN UNCOVERING THE TUBES FOR THE OPEN TECHNIQUE, ARE THEY RECAPPED ACCORDING TO THE INSTRUCTIONS BELOW? - PLACE THE STOPPER ON THE TUBE; - TWIST AND PUSH DOWN FIRMLY UNTIL THE COVER IS FULLY SEATED; A: THIS IS HOW THE STOPPER IS DONE AGAIN AND THE STOPPER IS PUSHED BY PRESSURE. ¿ DID THE PROBLEM OCCUR BEFORE, DURING, OR AFTER CENTRIFUGATION? A: BEFORE, THIS TUBE IS NOT CENTRIFUGED. ¿ IF DURING OR AFTER, WHAT WAS THE CENTRIFUGATION TIME AND SPEED? A: N/A. ¿IS THE PROPER CENTRIFUGE BUCKET USED FOR THE SIZE OF THE TUBES? THAT IS TO SAY: ARE THE TUBES TOO LARGE FOR THE BUCKET AND ARE THEY SUSPENDED BY THEIR LIDS (EG 1 AND 2 BELOW); OR IS THE BUCKET LARGER THAN THE TUBES AND THEY REMAIN COMPLETELY INSIDE IT (EX. 3 BELOW)? A: N/A ¿ARE THERE TUBES FROM THE SAME BATCH 2200108, BUT NOT USED (WITHOUT CONTAMINATION) AVAILABLE FOR EVALUATION? IF YES, COULD YOU PROVIDE US WITH A RANGE OF DAYS FOR COLLECTION? A: THE SALES EXECUTIVE ALREADY TOOK A SAMPLE OF THESE TUBES. H6. BD RECEIVED 3 PHOTOS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. THE PHOTOS SHOW TWO TUBES IN A BAG WITH BLOOD SPLATTER. THE HEMOGARD CLOSURE ASSEMBLY IS ATTACHED TO THE TUBE. THE PHOTOS DO NOT SHOW THE CUSTOMER¿S FAILURE MODE OF STOPPER POP OFF. EXPOSURE IS CONFIRMED AS BLOOD IS SEEN IN THE BAG ON THE OUTSIDE OF THE TUBES. ADDITIONALLY, 90 RETENTION SAMPLES FROM THE BD INVENTORY WERE VISUALLY INSPECTED WITH THE HEMOGARD CLOSURE ASSEMBLY CORRECTLY ASSEMBLED AND PLACED ON THE TUBES. THERE WERE NO COCKED STOPPERS IDENTIFIED THAT WOULD CAUSE THE HEMOGARD CLOSURE ASSEMBLY TO NOT BE APPLIED CORRECTLY. FURTHERMORE, 20 RETENTION SAMPLES WERE DRAW FUNCTIONALLY TESTED AND THE ISSUE OF STOPPER POP OFF WAS NOT OBSERVED AS ALL TEST RESULTS WERE WITHIN THE SPECIFICATION LIMITS. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE OF STOPPER POP OFF WITH THE RETENTION SAMPLE ANALYSIS RESULTS. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE OF EXPOSURE WITH THE PHOTO EVALUATION ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES D9: RETURNED TO MANUFACTURER ON: 2023-03-28 H.6. INVESTIGATION SUMMARY: BD RECEIVED 4 SAMPLES AND 3 PHOTOS IN SUPPORT OF THIS COMPLAINT FROM CATALOG 367861, LOT NUMBER 2200108. THE PHOTOS SHOW TWO TUBES IN A BAG WITH BLOOD SPLATTER. THE HEMOGARD CLOSURE ASSEMBLY IS ATTACHED TO THE TUBE. THE PHOTOS DO NOT SHOW THE CUSTOMER¿S FAILURE MODE OF STOPPER POP OFF. EXPOSURE IS CONFIRMED AS BLOOD IS SEEN IN THE BAG ON THE OUTSIDE OF THE TUBES. THE 4 SAMPLES WERE INSPECTED FOR DAMAGE WITH 0 VISIBLE DEFECTS. A DRAW TEST WAS PERFORMED AT THE MANUFACTURING SITE ON SAMPLE TUBES. THE TUBES WERE WITHIN SPECIFICATION LIMITS WITH NO ISSUES OBSERVED WITH THE STOPPER FUNCTION. ADDITIONALLY, 90 RETENTION SAMPLES WERE VISUALLY INSPECTED WITH THE HEMOGARD CLOSURE ASSEMBLY CORRECTLY ASSEMBLED AND PLACED ON THE TUBES. THERE WERE NO COCKED STOPPERS IDENTIFIED THAT WOULD CAUSE THE HEMOGARD CLOSURE ASSEMBLY TO NOT BE APPLIED CORRECTLY. 10 RETENTION SAMPLES WERE DRAW TESTED AND ALL WERE WITHIN SPECIFICATION. NO ISSUES WITH THE HEMOGARD CLOSURE ASSEMBLY BEING LOOSE OR SEPARATING DURING OR AFTER THE DRAW TESTING WAS COMPLETED. 20 RETENTION SAMPLES WERE TESTED FOR 1ST AND 2ND PULLOUT, TEST RESULTS WERE WITHIN THE SPECIFICATION LIMITS. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE OF STOPPER POP OFF WITH THE RETENTION SAMPLE ANALYSIS RESULTS. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE OF EXPOSURE WITH THE PHOTO EVALUATION ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBE THE STOPPER POPS OUT OF THE TUBE AND THERE IS SAMPLE LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE PURPLE CAPS TUBES SITUATION IN DETERMINED BATCHES, AFTER THEY ARE DECAPPED, THE STOPPERS POP OFF BY THEMSELVES AND THE SAMPLES ARE CONTINUOUSLY SPILLED, LEADING TO CONTAMINATION OF THE EQUIPMENT, HIGH BIOLOGICAL RISK, NEW SAMPLE ACQUISITION, AND DELAY IN RESULTS FOR CRITICAL PATIENTS, WHICH IS WHY IT'S EXTREMELY PRIORITIZED TO BE VERIFIED. STOPPER POP OFF FOR EDTA TUBE BATCH 2200108." ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON 13.MAR.2023: 1)BELOW IT IS REPORTED THAT THERE WAS CONTACT OF THE PATIENT'S BLOOD/BIOLOGICAL FLUIDS WITH THE PROFESSIONAL'S MUCOUS MEMBRANES (WHICH ARE EYES, MOUTH, NOSE). COULD YOU PLEASE CONFIRM THAT INFORMATION? WAS THERE THAT EXPOSURE? A: THERE WAS NO EXPOSURE AT THE MUCOSAL LEVEL, ONLY CONTACT WITH (GLOVED) HANDS. 2) IF SO, DID THE PROFESSIONALS DO ANY TESTS? DID THEY TAKE ANY PROPHYLACTIC MEDICATION? A: NOT APPLICABLE.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBE THE STOPPER POPS OUT OF THE TUBE AND THERE IS SAMPLE LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE PURPLE CAPS TUBES SITUATION IN DETERMINED BATCHES, AFTER THEY ARE DECAPPED, THE STOPPERS POP OFF BY THEMSELVES AND THE SAMPLES ARE CONTINUOUSLY SPILLED, LEADING TO CONTAMINATION OF THE EQUIPMENT, HIGH BIOLOGICAL RISK, NEW SAMPLE ACQUISITION, AND DELAY IN RESULTS FOR CRITICAL PATIENTS, WHICH IS WHY IT'S EXTREMELY PRIORITIZED TO BE VERIFIED. STOPPER POP OFF FOR EDTA TUBE BATCH 2200108." ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON 13.MAR.2023: 1)BELOW IT IS REPORTED THAT THERE WAS CONTACT OF THE PATIENT'S BLOOD/BIOLOGICAL FLUIDS WITH THE PROFESSIONAL'S MUCOUS MEMBRANES (WHICH ARE EYES, MOUTH, NOSE). COULD YOU PLEASE CONFIRM THAT INFORMATION? WAS THERE THAT EXPOSURE? A: THERE WAS NO EXPOSURE AT THE MUCOSAL LEVEL, ONLY CONTACT WITH (GLOVED) HANDS. 2) IF SO, DID THE PROFESSIONALS DO ANY TESTS? DID THEY TAKE ANY PROPHYLACTIC MEDICATION? A: NOT APPLICABLE. ADDITIONAL INFORMATION RECEIVED ON 13.MAR.2023: ¿ HOW MANY UNITS OF THE PRODUCT PRESENTED THE REPORTED DEVIATION? (AMOUNT AFFECTED / NUMBER OF EVENTS / SAMPLES AFFECTED); A: 11 UNITS IN THE LAST REVIEW CARRIED OUT (1 NIGHT SHIFT). ¿ IT MENTIONS ¿CERTAIN LOTS¿. WAS THE REPORTED INCIDENT NOTED ONLY IN LOT 2200108 OR WERE THERE OTHERS? IF THERE WERE OTHERS, PLEASE REPORT THE LOTS AFFECTED: A: LOT 2200108. ¿ WHAT IS THE OTHER PREVIOUS REFERENCE WHICH WOULD HAVE THE MOST CONTROLLED SITUATION? HAVE YOU REPORTED IT TO BD? PLEASE, INFORM BATCH AND CATALOG OF THE OTHER PRODUCTS THAT HAVE PRESENTED THE DEVIATION: A: EXECUTIVE SALES INFORMS THAT THAT REFERENCE HAS BEEN DISCONTINUED. (CHECK WITH HIM). ¿ HAS THERE BEEN EXPOSURE OF BLOOD FROM PATIENTS TO THE MUCOUS MEMBRANES OR SKIN OF PROFESSIONALS DUE TO EQUIPMENT CONTAMINATION AND BIOLOGICAL RISK? (DETAIL) A: YES THERE HAS BEEN. ¿ IF YES, PLEASE DESCRIBE THE POST-EXPOSURE PROPHYLACTIC ACTIONS TAKEN: A: CLEANING AND DISINFECTION. ¿ WAS THERE AN IMPACT DUE TO THE DELAYS IN THE RESULTS FOR CRITICALLY ILL PATIENTS? EG: DEATH, DAMAGE, CHANGE OF TREATMENT, DIAGNOSTIC ERROR, ETC.; A: DELAYS IN RESULTS, REDO SAMPLING, NON-QUALITY COSTS DUE TO REPROCESSING. ¿ PLEASE DESCRIBE THE IMPACT AND ACTIONS TAKEN BECAUSE OF IT: R: IMPACT ON PATIENT IN DELAYS AND RE-PUNCTURE, DISSATISFACTION, ACTION: TUBE VERIFICATION WITH ANOTHER PROVIDER. ¿ WHEN DO THE LIDS PUSH "BY THEMSELVES"? (EG: IN THE ANALYSIS EQUIPMENT, DURING CENTRIFUGATION, DURING TRANSPORT, ETC.); A: WHEN THEY ARE RESTING ON THE RACK, STAY STILL. ¿ WAS A SYRINGE USED TO DRAW BLOOD FROM THE OPEN SYSTEM AND THEN FILL THE TUBES? IF YES, WAS THE PLUNGER PUSHED INTO THE BLOOD? A: A SYRINGE WITHOUT A NEEDLE POINTED AT THE ARTERIAL LINE WAS USED TO TAKE THE SAMPLE, AS HAS ALWAYS BEEN DONE. ¿ DOES THE DIVERSION OCCUR ONLY WITH THE TUBES THAT WILL BE USED FOR INTAKE BY OPEN SYSTEM? A: IT IS NOT EASY TO IDENTIFY. ¿ IF DRIFT ALSO OCCURS WITH CLOSED INTAKE TUBES, WHAT ACQUISITION DEVICE WAS USED? WAS IT FROM BD? A: N/A ¿ IF THE DRIFT ALSO OCCURS WITH CLOSED INTAKE TUBES, WAS A HOLDER USED? WAS IT THE BD HOLDER? A: N/A ¿ COULD YOU SEND PHOTOS AND/OR VIDEOS SO THAT IT IS POSSIBLE TO OBSERVE THE REPORTED DEVIATION? A: THEY WERE SENT TO THE SALES EXECUTIVE. ¿ WHEN UNCOVERING THE TUBES FOR THE OPEN TECHNIQUE, ARE THEY RECAPPED ACCORDING TO THE INSTRUCTIONS BELOW? - PLACE THE STOPPER ON THE TUBE; - TWIST AND PUSH DOWN FIRMLY UNTIL THE COVER IS FULLY SEATED; A: THIS IS HOW THE STOPPER IS DONE AGAIN AND THE STOPPER IS PUSHED BY PRESSURE. ¿ DID THE PROBLEM OCCUR BEFORE, DURING, OR AFTER CENTRIFUGATION? A: BEFORE, THIS TUBE IS NOT CENTRIFUGED. ¿ IF DURING OR AFTER, WHAT WAS THE CENTRIFUGATION TIME AND SPEED? A: N/A. ¿IS THE PROPER CENTRIFUGE BUCKET USED FOR THE SIZE OF THE TUBES? THAT IS TO SAY: ARE THE TUBES TOO LARGE FOR THE BUCKET AND ARE THEY SUSPENDED BY THEIR LIDS (EG 1 AND 2 BELOW); OR IS THE BUCKET LARGER THAN THE TUBES AND THEY REMAIN COMPLETELY INSIDE IT (EX. 3 BELOW)? A: N/A ¿ARE THERE TUBES FROM THE SAME BATCH 2200108, BUT NOT USED (WITHOUT CONTAMINATION) AVAILABLE FOR EVALUATION? IF YES, COULD YOU PROVIDE US WITH A RANGE OF DAYS FOR COLLECTION? A: THE SALES EXECUTIVE ALREADY TOOK A SAMPLE OF THESE TUBES.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBE THE STOPPER POPS OUT OF THE TUBE AND THERE IS SAMPLE LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE PURPLE CAPS TUBES SITUATION IN DETERMINED BATCHES, AFTER THEY ARE DECAPPED, THE STOPPERS POP OFF BY THEMSELVES AND THE SAMPLES ARE CONTINUOUSLY SPILLED, LEADING TO CONTAMINATION OF THE EQUIPMENT, HIGH BIOLOGICAL RISK, NEW SAMPLE ACQUISITION, AND DELAY IN RESULTS FOR CRITICAL PATIENTS, WHICH IS WHY IT'S EXTREMELY PRIORITIZED TO BE VERIFIED. STOPPER POP OFF FOR EDTA TUBE BATCH 2200108." ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON 13.MAR.2023: 1)BELOW IT IS REPORTED THAT THERE WAS CONTACT OF THE PATIENT'S BLOOD/BIOLOGICAL FLUIDS WITH THE PROFESSIONAL'S MUCOUS MEMBRANES (WHICH ARE EYES, MOUTH, NOSE). COULD YOU PLEASE CONFIRM THAT INFORMATION? WAS THERE THAT EXPOSURE? A: THERE WAS NO EXPOSURE AT THE MUCOSAL LEVEL, ONLY CONTACT WITH (GLOVED) HANDS. IF SO, DID THE PROFESSIONALS DO ANY TESTS? DID THEY TAKE ANY PROPHYLACTIC MEDICATION? NOT APPLICABLE. ADDITIONAL INFORMATION RECEIVED ON 13.MAR.2023: HOW MANY UNITS OF THE PRODUCT PRESENTED THE REPORTED DEVIATION? (AMOUNT AFFECTED/NUMBER OF EVENTS/SAMPLES AFFECTED); (B)(4) UNITS IN THE LAST REVIEW CARRIED OUT (1 NIGHT SHIFT). IT MENTIONS ¿CERTAIN LOTS¿. WAS THE REPORTED INCIDENT NOTED ONLY IN LOT 2200108 OR WERE THERE OTHERS? IF THERE WERE OTHERS, PLEASE REPORT THE LOTS AFFECTED: LOT 2200108. WHAT IS THE OTHER PREVIOUS REFERENCE WHICH WOULD HAVE THE MOST CONTROLLED SITUATION? HAVE YOU REPORTED IT TO BD? PLEASE, INFORM BATCH AND CATALOG OF THE OTHER PRODUCTS THAT HAVE PRESENTED THE DEVIATION: EXECUTIVE SALES INFORMS THAT THAT REFERENCE HAS BEEN DISCONTINUED. (CHECK WITH HIM). HAS THERE BEEN EXPOSURE OF BLOOD FROM PATIENTS TO THE MUCOUS MEMBRANES OR SKIN OF PROFESSIONALS DUE TO EQUIPMENT CONTAMINATION AND BIOLOGICAL RISK? (DETAIL): YES THERE HAS BEEN. IF YES, PLEASE DESCRIBE THE POST-EXPOSURE PROPHYLACTIC ACTIONS TAKEN: CLEANING AND DISINFECTION. WAS THERE AN IMPACT DUE TO THE DELAYS IN THE RESULTS FOR CRITICALLY ILL PATIENTS? EG: DEATH, DAMAGE, CHANGE OF TREATMENT, DIAGNOSTIC ERROR, ETC.: DELAYS IN RESULTS, REDO SAMPLING, NON-QUALITY COSTS DUE TO REPROCESSING. PLEASE DESCRIBE THE IMPACT AND ACTIONS TAKEN BECAUSE OF IT: IMPACT ON PATIENT IN DELAYS AND RE-PUNCTURE, DISSATISFACTION, ACTION: TUBE VERIFICATION WITH ANOTHER PROVIDER. WHEN DO THE LIDS PUSH "BY THEMSELVES"? (EG: IN THE ANALYSIS EQUIPMENT, DURING CENTRIFUGATION, DURING TRANSPORT, ETC.); WHEN THEY ARE RESTING ON THE RACK, STAY STILL. WAS A SYRINGE USED TO DRAW BLOOD FROM THE OPEN SYSTEM AND THEN FILL THE TUBES? IF YES, WAS THE PLUNGER PUSHED INTO THE BLOOD? A SYRINGE WITHOUT A NEEDLE POINTED AT THE ARTERIAL LINE WAS USED TO TAKE THE SAMPLE, AS HAS ALWAYS BEEN DONE. DOES THE DIVERSION OCCUR ONLY WITH THE TUBES THAT WILL BE USED FOR INTAKE BY OPEN SYSTEM? IT IS NOT EASY TO IDENTIFY. IF DRIFT ALSO OCCURS WITH CLOSED INTAKE TUBES, WHAT ACQUISITION DEVICE WAS USED? WAS IT FROM BD? N/A. IF THE DRIFT ALSO OCCURS WITH CLOSED INTAKE TUBES, WAS A HOLDER USED? WAS IT THE BD HOLDER? N/A. COULD YOU SEND PHOTOS AND/OR VIDEOS SO THAT IT IS POSSIBLE TO OBSERVE THE REPORTED DEVIATION? THEY WERE SENT TO THE SALES EXECUTIVE. WHEN UNCOVERING THE TUBES FOR THE OPEN TECHNIQUE, ARE THEY RECAPPED ACCORDING TO THE INSTRUCTIONS BELOW? PLACE THE STOPPER ON THE TUBE; TWIST AND PUSH DOWN FIRMLY UNTIL THE COVER IS FULLY SEATED; THIS IS HOW THE STOPPER IS DONE AGAIN AND THE STOPPER IS PUSHED BY PRESSURE. DID THE PROBLEM OCCUR BEFORE, DURING, OR AFTER CENTRIFUGATION? BEFORE, THIS TUBE IS NOT CENTRIFUGED. IF DURING OR AFTER, WHAT WAS THE CENTRIFUGATION TIME AND SPEED? N/A. IS THE PROPER CENTRIFUGE BUCKET USED FOR THE SIZE OF THE TUBES? THAT IS TO SAY: ARE THE TUBES TOO LARGE FOR THE BUCKET AND ARE THEY SUSPENDED BY THEIR LIDS (EG 1 AND 2 BELOW); OR IS THE BUCKET LARGER THAN THE TUBES AND THEY REMAIN COMPLETELY INSIDE IT (EX. 3 BELOW)? N/A. ARE THERE TUBES FROM THE SAME BATCH 2200108, BUT NOT USED (WITHOUT CONTAMINATION) AVAILABLE FOR EVALUATION? IF YES, COULD YOU PROVIDE US WITH A RANGE OF DAYS FOR COLLECTION? THE SALES EXECUTIVE ALREADY TOOK A SAMPLE OF THESE TUBES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 769065 | BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBE | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO. (BROKEN BOW) | 367861 | SEE H.10 | 50382903678612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |