BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES
Report
- Report Number
- 1917413-2024-00403
- Event Type
- Malfunction
- Date Received
- May 10, 2024
- Date of Event
- April 15, 2024
- Report Date
- June 18, 2024
- Manufacturer
- BECTON, DICKINSON & CO. (BROKEN BOW)
- Product Code
- GIM
- UDI-DI
- 30382903678564
- PMA / PMN Number
- BK230980
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING WAS UPDATED : INVESTIGATION SUMMARY MATERIAL #: 367856. LOT/BATCH #: 3163664. BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR DAMAGED TUBE INTERIOR WAS OBSERVED. ADDITIONALLY, 100 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO DAMAGED TUBE INTERIOR AS ALL SAMPLES MET SPECIFICATIONS. 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 HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE DAMAGED TUBE INTERIOR. 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.
H.6 INVESTIGATION SUMMARY. BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR DAMAGED TUBE INTERIOR WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 100 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO DAMAGED TUBE INTERIOR AS ALL SAMPLES MET SPECIFICATIONS. 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 DAMAGED TUBE INTERIOR. 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.
D.2. MEDICAL DEVICE TYPE: ONE ADDITIONAL CODE APPLIES, JKA. G.5. PMA/510(K)#: TWO ADDITIONAL CODES APPLY, K213670, K231373. 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 AFTER DRAWING BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, A DEFORMED PLASTIC PROJECTION WAS FOUND ON THE INNER TUBE WALL. NO IMPACT WAS REPORTED.
IT WAS REPORTED THAT AFTER DRAWING BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, A DEFORMED PLASTIC PROJECTION WAS FOUND ON THE INNER TUBE WALL. NO IMPACT WAS REPORTED.
IT WAS REPORTED THAT AFTER DRAWING BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES, A DEFORMED PLASTIC PROJECTION WAS FOUND ON THE INNER TUBE WALL. NO IMPACT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2535508 | BD VACUTAINER® K2 EDTA (K2E) 5.4MG BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | GIM | BECTON, DICKINSON & CO. (BROKEN BOW) | 3163664 | 30382903678564 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |