BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES
Report
- Report Number
- 1917413-2023-00616
- Event Type
- Malfunction
- Date Received
- June 28, 2023
- Date of Event
- June 15, 2023
- Report Date
- October 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
- CI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY: "MATERIAL #: 367861. LOT/BATCH #: 2109082, 2048406, & 2109077. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, TEN (10) RETENTION SAMPLES OF EACH LOT FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO UNDERFILL AS ALL SAMPLES MET SPECIFICATIONS. ADDITIONALLY, ONE HUNDRED (100) RETAINS OF LOTS 2109082 AND 2109077 WERE VISUALLY EXAMINED WITH NO ISSUES RELATING TO UNDERFILL. NINETY (90) RETAINS OF LOT 2048406 WERE VISUALLY EXAMINED WITH NO ISSUES RELATING TO UNDERFILL. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE OF UNDERFILL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. HOWEVER, TO ENSURE THAT TUBES DRAW TO AN ACCEPTABLE VOLUME A NUMBER OF FACTORS SHOULD BE CONSIDERED: EVACUATED TUBES ARE DESIGNED TO DRAW THE VOLUME INDICATED. FILLING IS COMPLETE WHEN VACUUM NO LONGER CONTINUES TO DRAW. WHEN USING A WINGED BLOOD COLLECTION SET FOR VENIPUNCTURE A DISCARD TUBE SHOULD BE DRAWN FIRST TO ENSURE THE BLOOD COLLECTION SET TUBING¿S ¿DEAD SPACE¿ IS FILLED WITH BLOOD. THE QUANTITY OF BLOOD DRAWN VARIES WITH ALTITUDE, AMBIENT TEMPERATURE, BAROMETRIC PRESSURE, AGE OF THE TUBE, VENOUS PRESSURE AND FILLING TECHNIQUE. TUBES WITH SMALLER DRAW VOLUMES (PARTIAL DRAW TUBES DENOTED BY TRANSLUCENT CLOSURES) MAY FILL MORE SLOWLY, DUE TO THE LOWER VACUUM, THAN TUBES OF THE SAME SIZE WITH LARGER DRAW VOLUMES. KEY FACTORS TO ENSURE THE CORRECT VACUUM DRAW: ENSURE STORAGE TEMPERATURE IS CORRECT (4°C - 25°C). ENSURE THE BLOOD COLLECTION SYSTEM IS ASSEMBLED CORRECTLY. ENSURE A DISCARD TUBE IS USED WITH A BLOOD COLLECTION SET. ENSURE PROPER NEEDLE POSITIONING IN THE PATIENT¿S VEIN DURING THE VENIPUNCTURE. ENSURE THE TUBE IS PLACED CENTRALLY IN THE NEEDLE HOLDER FOR COMPLETE PUNCTURE OF THE STOPPER. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS."
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT#: 2109082, D4. MEDICAL DEVICE EXPIRATION DATE: 31-08-2023, H4. DEVICE MANUFACTURE DATE: 19-04-2022. D4. MEDICAL DEVICE LOT#: 2048406, D4. MEDICAL DEVICE EXPIRATION DATE: 30-06-2023, H4. DEVICE MANUFACTURE DATE: 17-02-2022. D4. MEDICAL DEVICE LOT#: 2109077, D4. MEDICAL DEVICE EXPIRATION DATE: 31-08-2023, H4. DEVICE MANUFACTURE DATE: 19-04-2022. D4. MEDICAL DEVICE LOT#: 2181429, D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, H4. DEVICE MANUFACTURE DATE: UNKNOWN. E.1. INITIAL REPORTER FACILITY NAME: HOSPITAL (B)(6) H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT WHILE USE OF BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES, THERE IS UNDERFILLING OF TUBES ACROSS THREE LOT NUMBERS. EXACT NUMBER OF OCCURRENCES IS UNKNOWN. THERE IS NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER MENTIONS THAT 4 ML EDTA TUBES DO NOT FILL TO AN ADEQUATE LEVEL, HAVING AN APPROXIMATE DEFICIT OF 20 TO 25%. THE LOTS ARE 4: 2181429 - 2109082 - 2048406 - 2109077."
IT WAS REPORTED THAT WHILE USE OF BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES, THERE IS UNDERFILLING OF TUBES ACROSS THREE LOT NUMBERS. EXACT NUMBER OF OCCURRENCES IS UNKNOWN. THERE IS NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER MENTIONS THAT 4 ML EDTA TUBES DO NOT FILL TO AN ADEQUATE LEVEL, HAVING AN APPROXIMATE DEFICIT OF 20 TO 25%. THE LOTS ARE 4: 2181429 - 2109082 - 2048406 - 2109077."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1702412 | BD VACUTAINER® K2 EDTA (K2E) 7.2MG BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO. (BROKEN BOW) | 367861 | SEE H.10 | 50382903678612 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |