BD MINIDRAW¿ H&H CAPILLARY BLOOD COLLECTION TUBE
Report
- Report Number
- 2618282-2024-00119
- Event Type
- Malfunction
- Date Received
- September 3, 2024
- Date of Event
- July 30, 2024
- Report Date
- May 23, 2025
- Manufacturer
- BD CARIBE LTD.
- Product Code
- GIM
- UDI-DI
- 50382903666039
- 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
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 29-MAY-2024. INVESTIGATION SUMMARY : MATERIAL #: 366603; LOT/BATCH #: 4024091. BD RECEIVED TEN (10) CUSTOMER RETURNED SAMPLES FOR INVESTIGATION VIA RELATED COMPLAINT (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, EIGHT (8) RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO THE INDICATED FAILURE MODE CLOTTING. 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 (B)(4). 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 AND 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.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION (REMOVAL OF STATEMENT INDICATING THE SAMPLE WAS RECOLLECTED): B.5. "IT WAS REPORTED WHEN USING THE BD MINIDRAW¿ H&H CAPILLARY BLOOD COLLECTION TUBE THERE WAS CLOTTING IN ONE SAMPLE. THERE WERE NO OTHER HEALTH CONSEQUENCES OR IMPACTS REPORTED."
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 WHEN USING THE BD MINIDRAW¿ H&H CAPILLARY BLOOD COLLECTION TUBE THERE WAS CLOTTING IN ONE SAMPLE. THE SAMPLE WAS RECOLLECTED. THERE WERE NO OTHER HEALTH CONSEQUENCES OR IMPACTS REPORTED.
IT WAS REPORTED WHEN USING THE BD MINIDRAW¿ H&H CAPILLARY BLOOD COLLECTION TUBE THERE WAS CLOTTING IN ONE SAMPLE. THERE WERE NO OTHER HEALTH CONSEQUENCES OR IMPACTS REPORTED.
IT WAS REPORTED WHEN USING THE BD MINIDRAW¿ H&H CAPILLARY BLOOD COLLECTION TUBE THERE WAS CLOTTING IN ONE SAMPLE. THE SAMPLE WAS RECOLLECTED. THERE WERE NO OTHER HEALTH CONSEQUENCES OR IMPACTS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 735046 | BD MINIDRAW¿ H&H CAPILLARY BLOOD COLLECTION TUBE | CAPILLARY BLOOD COLLECTION TUBE IVD | GIM | BD CARIBE LTD. | 4024091 | 50382903666039 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |