BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES
Report
- Report Number
- 1917413-2022-00298
- Event Type
- Malfunction
- Date Received
- June 2, 2022
- Date of Event
- May 18, 2022
- Report Date
- June 3, 2022
- 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
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H.6. INVESTIGATION: NO CUSTOMER SAMPLES AND NO PHOTOS WERE RECEIVED IN SUPPORT OF THIS COMPLAINT. THEREFORE, 10 IN-HOUSE RETENTION TUBES FROM THE BD INVENTORY WERE INSPECTED WITH 0 VISIBLE DEFECTS. FUNCTIONAL TESTING WAS PERFORMED ON THE SAMPLES AND THE CUSTOMER'S INDICATED FAILURE MODE OF UNDERFILL WAS NOT OBSERVED AS ALL TUBES WERE WITHIN SPECIFICATION LIMITS. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE NO SAMPLES WERE RECEIVED, AND THE DEFECT WAS NOT OBSERVED IN THE RETENTION SAMPLE TESTING. THE QUANTITY OF BLOOD DRAWN INTO EVALUATED TUBES VARIES WITH ALTITUDE, AMBIENT TEMPERATURE, BAROMETRIC PRESSURE, TUBE AGE, VENOUS PRESSURE, AND FILLING TECHNIQUE. 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 TUBES ARE UNDERFILLING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: AT THE MOMENT OF SAMPLE DRAW THE TUBES FILL UNDER THE LIMIT ALLOWED, WHICH IT'S REQUIRED TO ASSURE ACCURATE RESULTS FOR DIAGNOSTIC SUPPORT. COULD YOU CONFIRM IF THE PRODUCT LOT (1098448) IS CORRECT? R: LOT 1098448 WAS REPORTED FROM VARIOUS SERVICE POINTS NATIONALLY LEVEL, AND LOT 1288702 REPORTED IN THE CITY OF THIS COMPLAINT. HOW MANY UNITS OF THE PRODUCT PRESENTED THE REPORTED DEVIATION? (AMOUNT AFFECTED); R: THERE IS NO EXACT DATA, THE TUBES USED WITH INSUFFICIENT FILLING WERE 5347. TAKING INTO ACCOUNT THE DISTRIBUTION TO THE FACILITIES THAT REPORT THE FAILURE. HAS THERE BEEN ANY HARM TO THE PATIENT/HEALTHCARE PROFESSIONAL? (EG: NEW SAMPLE COLLECTION, ERRONEOUS TEST RESULTS, DIAGNOSTIC ERROR, ETC. - DETAIL), R: YES, REPEAT SAMPLE COLLECTION. WAS THERE A NEED FOR MEDICAL INTERVENTION DUE TO WHAT HAPPENED (CHANGE IN CLINICAL TREATMENT, MEDICATION ADMINISTRATION, ETC.)? (DETAIL). R: NO, SINCE THE TUBES THAT PRESENTED INSUFFICIENT FILLING WERE TAKEN AGAIN. ARE TUBES FROM THE SAME LOT, BUT WITHOUT CONTAMINATION, AVAILABLE FOR EVALUATION? IF YES, COULD YOU TELL US HOW MANY AND A RANGE OF DAYS FOR COLLECTION? R: 18935 TUBES FROM LOT 1098448 WERE RETURNED TO THE DISTRIBUTOR, OF WHICH 2435 WILL NOT BE RECOGNIZED BECAUSE THEY ARE NOT IN THE ORIGINAL PACKAGING, THESE HAVE NOT YET BEEN RETURNED TO THE LME, THEY ARE IN OUR CUSTODY. WHAT IS THE RATE OF OCCURRENCE/FREQUENCY OF THE DEVIATION? (EX: 1 DAY, % OF TUBES AFFECTED, PATIENTS INVOLVED, HOW MANY EXAMS PER DAY, ETC.); R: THERE IS NO EXACT DATA, THE NUMBER OF TUBES DISTRIBUTED TO THE PDS THAT REPORTED THE EVENT WAS 6682, OF WHICH 1335 WERE RETURNED, TAKING INTO ACCOUNT THE TOTAL NUMBER OF TUBES USED, THE % THAT SHOWED INSUFFICIENT FILLING WAS ABOUT 19%. DID IT OCCUR WITH A PARTICULAR DEPARTMENT (EG, HEALTH UNIT, DAY SHIFT, TIME OF DAY, PERSON, ETC.)? R: NO, IT WAS PRESENTED AT THE DIFFERENT SERVICE POINTS NATIONWIDE HOW MANY LOCATIONS AFFECTED? (HOSPITALS, OUTPATIENT CLINICS, ETC.); R: 4 FACILITIES POINTS LOCATED IN 3 CITIES; WAS A SUCCESSFUL SAMPLE TAKEN FROM THE SAME LOT? R: YES, MOST OF THE FACILITIES REPORTED NO PROBLEMS. HOW WERE THE TUBES REJECTED? (EG: DURING SAMPLE COLLECTION, IN THE LABORATORY, ETC.): R: DURING SAMPLE COLLECTION. HOW WERE THE TUBES FILLED? R: FOLLOWING THE PROTOCOLS ESTABLISHED FOR THE USE OF THE VACUTAINER SYSTEM WAS A DISCARD TUBE USED? R: WHAT DOES IT REFER TO? WHAT IS THE SAMPLING METHOD (EG, STRAIGHT NEEDLE, WINGSET, SYRINGE, ETC.)? R: VACUTAINER SYSTEM. IF A WINGSET WAS USED, WERE ALL CONNECTIONS CHECKED FOR SECURITY? R: NO WINGSET USED. WAS A BD PRODUCT USED TO TRANSFER THE BLOOD INTO THE TUBES? IF YES, WHICH ONE? R: YES, BD NEEDLES AND HOLDERS. HAVE THE TUBES BEEN EXPOSED TO HEAT? R: NO, THESE ARE STORED IN A TEMPERATURE AND HUMIDITY CONTROLLED ENVIRONMENT.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES ARE UNDERFILLING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: AT THE MOMENT OF SAMPLE DRAW THE TUBES FILL UNDER THE LIMIT ALLOWED, WHICH IT'S REQUIRED TO ASSURE ACCURATE RESULTS FOR DIAGNOSTIC SUPPORT. - COULD YOU CONFIRM IF THE PRODUCT LOT (1098448) IS CORRECT? R: LOT 1098448 WAS REPORTED FROM VARIOUS SERVICE POINTS NATIONALLY LEVEL, AND LOT 1288702 REPORTED IN THE CITY OF THIS COMPLAINT. - HOW MANY UNITS OF THE PRODUCT PRESENTED THE REPORTED DEVIATION? (AMOUNT AFFECTED); R: THERE IS NO EXACT DATA, THE TUBES USED WITH INSUFFICIENT FILLING WERE 5347. TAKING INTO ACCOUNT THE DISTRIBUTION TO THE FACILITIES THAT REPORT THE FAILURE - HAS THERE BEEN ANY HARM TO THE PATIENT/HEALTHCARE PROFESSIONAL? (EG: NEW SAMPLE COLLECTION, ERRONEOUS TEST RESULTS, DIAGNOSTIC ERROR, ETC. - DETAIL), R: YES, REPEAT SAMPLE COLLECTION. - WAS THERE A NEED FOR MEDICAL INTERVENTION DUE TO WHAT HAPPENED (CHANGE IN CLINICAL TREATMENT, MEDICATION ADMINISTRATION, ETC.)? (DETAIL). R: NO, SINCE THE TUBES THAT PRESENTED INSUFFICIENT FILLING WERE TAKEN AGAIN. - ARE TUBES FROM THE SAME LOT, BUT WITHOUT CONTAMINATION, AVAILABLE FOR EVALUATION? IF YES, COULD YOU TELL US HOW MANY AND A RANGE OF DAYS FOR COLLECTION? R: 18935 TUBES FROM LOT 1098448 WERE RETURNED TO THE DISTRIBUTOR, OF WHICH 2435 WILL NOT BE RECOGNIZED BECAUSE THEY ARE NOT IN THE ORIGINAL PACKAGING, THESE HAVE NOT YET BEEN RETURNED TO THE LME, THEY ARE IN OUR CUSTODY. - WHAT IS THE RATE OF OCCURRENCE/FREQUENCY OF THE DEVIATION? (EX: 1 DAY, % OF TUBES AFFECTED, PATIENTS INVOLVED, HOW MANY EXAMS PER DAY, ETC.); R: THERE IS NO EXACT DATA, THE NUMBER OF TUBES DISTRIBUTED TO THE PDS THAT REPORTED THE EVENT WAS 6682, OF WHICH 1335 WERE RETURNED, TAKING INTO ACCOUNT THE TOTAL NUMBER OF TUBES USED, THE % THAT SHOWED INSUFFICIENT FILLING WAS ABOUT 19%. - DID IT OCCUR WITH A PARTICULAR DEPARTMENT (EG, HEALTH UNIT, DAY SHIFT, TIME OF DAY, PERSON, ETC.)? R: NO, IT WAS PRESENTED AT THE DIFFERENT SERVICE POINTS NATIONWIDE. - HOW MANY LOCATIONS AFFECTED? (HOSPITALS, OUTPATIENT CLINICS, ETC.); R: 4 FACILITIES POINTS LOCATED IN 3 CITIES; - WAS A SUCCESSFUL SAMPLE TAKEN FROM THE SAME LOT? R: YES, MOST OF THE FACILITIES REPORTED NO PROBLEMS. - HOW WERE THE TUBES REJECTED? (EG: DURING SAMPLE COLLECTION, IN THE LABORATORY, ETC.): R: DURING SAMPLE COLLECTION. - HOW WERE THE TUBES FILLED? R: FOLLOWING THE PROTOCOLS ESTABLISHED FOR THE USE OF THE VACUTAINER SYSTEM. - WAS A DISCARD TUBE USED? R: WHAT DOES IT REFER TO? - WHAT IS THE SAMPLING METHOD (EG, STRAIGHT NEEDLE, WINGSET, SYRINGE, ETC.)? R: VACUTAINER SYSTEM. - IF A WINGSET WAS USED, WERE ALL CONNECTIONS CHECKED FOR SECURITY? R: NO WINGSET USED. - WAS A BD PRODUCT USED TO TRANSFER THE BLOOD INTO THE TUBES? IF YES, WHICH ONE? R: YES, BD NEEDLES AND HOLDERS. - HAVE THE TUBES BEEN EXPOSED TO HEAT? R: NO, THESE ARE STORED IN A TEMPERATURE AND HUMIDITY CONTROLLED ENVIRONMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 159155 | BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO. (BROKEN BOW) | 367861 | 1288702 | 50382903678612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |