BD MINIDRAW¿ H&H CAPILLARY BLOOD COLLECTION TUBE
Report
- Report Number
- 2618282-2024-00090
- Event Type
- Malfunction
- Date Received
- July 30, 2024
- Date of Event
- June 25, 2024
- Report Date
- September 5, 2024
- Manufacturer
- BD CARIBE LTD.
- Product Code
- GIM
- PMA / PMN Number
- K230493
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 30-MAY-2024. INVESTIGATION SUMMARY: MATERIAL #: 366603. LOT/BATCH #: 4024091. BD RECEIVED TEN (10) CUSTOMER RETURNED SAMPLES FOR INVESTIGATION VIA RELATED COMPLAINT PR (B)(4). THE TEN SAMPLES WERE EVALUATED BY FUNCTIONAL TESTING FOR FACTORS RELATING TO THE INDICATED FAILURE MODE OF CLOTTING, AND NO ISSUES WERE OBSERVED. ADDITIONALLY, BD RECEIVED YOUR CUSTOMER COMPLAINT RELATED TO PLATELET CLUMPING. IT IS IMPORTANT TO NOTE THAT USAGE OF THIS PRODUCT FOR PLATELET COUNT IS CONSIDERED AN OFF-LABEL USE. THE INTENDED USE IS LIMITED TO SAMPLE COLLECTION USED IN THE MEASUREMENT OF HEMOGLOBIN (HGB) & HEMATOCRIT (HCT), WHEN ANALYZED ON SYSMEX XN - SERIES¿ SYSTEMS. LIMITATION NOTES ARE INCLUDED IN THE IFU AND PRINTED ON THE TUBE UNIT LABEL. NEVERTHELESS, EIGHT (8) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO THE INDICATED FAILURE MODES. EIGHT (8) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO CLOTTING OR PLATELET CLUMPING. RETENTION SAMPLE TESTING REVEALED ALL SAMPLES MET THE PERFORMANCE SPECIFICATIONS OUTLINED IN THE STANDARD FOR SINGLE-USE CONTAINERS FOR HUMAN VENOUS BLOOD SPECIMEN COLLECTION (ISO6710). BD REQUESTED ADDITIONAL RETURN SAMPLES TO FURTHER EVALUATE THE PERFORMANCE OF THE DEVICE THROUGH AN INTERNAL BD CLINICAL STUDY. ONE-HUNDRED AND FIFTY (150) CUSTOMER SAMPLES WERE RECEIVED FOR FURTHER EVALUATION. OF THOSE, 67 CUSTOMER SAMPLES WERE EVALUATED VIA A CLINICAL STUDY EVALUATION. THE STUDY DID NOT OBSERVE ANY SAMPLE CLOTTING ISSUES WHEN SAMPLES WERE COLLECTED ACCORDING TO THE PRODUCT IFU. NO MACROSCOPIC CLOTS WERE OBSERVED FOR ANY SUCCESSFUL COLLECTIONS, EITHER IMMEDIATELY AFTER COLLECTION OR AFTER ~24 HOURS OF REFRIGERATION. THE STUDY REVEALED ALL SAMPLES TESTED MET SPECIFICATION, AND THE RATE OF OBSERVED CLOTS WAS 0%. FURTHERMORE, BD PERFORMED A CLINICAL STUDY ON THE SAME 67 RETURNED SAMPLES TO VERIFY THE DESIGN OF THE DEVICE MET ITS INTENDED USE. SEVEN (7) OF THE SIXTY-SEVEN (67) SAMPLES WERE FLAGGED FOR PLATELET CLUMPS (10.4%). NONE OF THESE SAMPLES SHOWED VISUAL EVIDENCE OF PLATELET CLUMPS UPON SMEAR REVIEW. THEREFORE, ALL SAMPLES TESTED 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 CLOTTING OR PLATELET CLUMPING. NO DEFINITIVE ROOT CAUSE WAS IDENTIFIED. 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. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.
IT WAS REPORTED WHEN USING THE BD MINIDRAW¿ H&H CAPILLARY BLOOD COLLECTION TUBE THERE WAS BLOOD CLOTTING IN ONE SAMPLE AND PLATELET CLUMPING IN 3 SAMPLES. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.
IT WAS REPORTED WHEN USING THE BD MINIDRAW¿ H&H CAPILLARY BLOOD COLLECTION TUBE THERE WAS BLOOD CLOTTING IN ONE SAMPLE AND PLATELET CLUMPING IN 3 SAMPLES. THERE WERE NO HEALTH CONSEQUENCES OR IMPACTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 216334 | BD MINIDRAW¿ H&H CAPILLARY BLOOD COLLECTION TUBE | BLOOD SPECIMEN COLLECTION DEVICE | GIM | BD CARIBE LTD. | 4024091 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |