BD MICROTAINER® TUBES WITH K2E (K2EDTA)
Report
- Report Number
- 2243072-2023-00532
- Event Type
- Malfunction
- Date Received
- March 29, 2023
- Date of Event
- March 8, 2023
- Report Date
- June 14, 2023
- Manufacturer
- BECTON DICKINSON
- Product Code
- JKA
- UDI-DI
- 50382903659741
- PMA / PMN Number
- K991702
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6. INVESTIGATION SUMMARY: BD RECEIVED 16 SAMPLES AND 2 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED; CLOTTING WAS NOT OBSERVED. BOTH PHOTOS SHOW UNUSED MICROTAINERS SHOWING THE LOT # FOR BATCH VERIFICATION. THE CUSTOMER SAMPLES ALONG WITH RETENTION SAMPLES FROM BD INVENTORY, WERE VISUALLY EVALUATED WITH NO DEFECTS OBSERVED. ADDITIONALLY, CUSTOMER RETURNED SAMPLES AND RETENTION SAMPLES WERE TESTED FOR K2 EDTA CONTENT: 1 SAMPLE FROM CUSTOMER RETURNS ON LOT 2301960 WAS BELOW SPECIFICATION. 2 RETENTION SAMPLES FROM LOT 2250752 WERE BELOW SPECIFICATION. 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. A COMPLAINT HISTORY WAS PERFORMED AND ONLY THE CURRENT COMPLAINT WAS FOUND RELATING TO THE INCIDENT LOT NUMBERS AND THE ¿AS REPORTED¿ DEFECT CODE; THEREFORE NO TREND WAS FOUND. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE (CLOTTING)ON LOT 2250752 AND 2301960 VIA TESTING OF RETAIN AND RETURNED SAMPLES. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. 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. CUSTOMER RECOMMENDATION: SPECIAL CARE SHOULD BE TAKEN WHEN NEONATAL/PEDIATRIC COLLECTIONS ARE PERFORMED IN TERMS OF BOTH, VOLUME COLLECTED AND BOTH PROPER AND ADEQUATE SPECIMEN MIXING. ADHERING TO RECOMMENDED SPECIMEN HANDLING AND PROCESSING STEPS WILL FACILITATE ACCEPTABLE SPECIMEN QUALITY AND OVERALL PERFORMANCE FOR RELIABLE ANALYTICAL OUTCOMES. THE MOST COMMON CAUSE OF CLOTTING IS INADEQUATE AND/OR IMPROPER MIXING. A REVIEW OF SPECIMEN HANDLING AND STORAGE PARAMETERS IS RECOMMENDED FOR THIS TUBE TYPE. H3 OTHER TEXT : SEE H.10.
THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT#: 2250752. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. MEDICAL DEVICE LOT#: 2301960. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 BD MICROTAINER® TUBES WITH K2E (K2EDTA) TUBES FROM THESE LOT # 2250752 AND LOT#2301960 ARE CLOTTING EDTA MICROTAINER TUBES. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS AN ISSUE OF EDTA MICROTAINER 365974 TUBES CLOTTING. LOT#: 2250752 AND LOT#: 2250752.
IT WAS REPORTED THAT BD MICROTAINER® TUBES WITH K2E (K2EDTA) TUBES FROM THESE LOT # 2250752 AND LOT#2301960 ARE CLOTTING EDTA MICROTAINER TUBES. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS AN ISSUE OF EDTA MICROTAINER 365974 TUBES CLOTTING. LOT#: 2250752 AND LOT#: 2250752
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 443269 | BD MICROTAINER® TUBES WITH K2E (K2EDTA) | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON DICKINSON | 365974 | SEE H.10 | 50382903659741 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |