BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE
Report
- Report Number
- 1917413-2025-00237
- Event Type
- Malfunction
- Date Received
- March 12, 2025
- Date of Event
- February 12, 2025
- Report Date
- June 27, 2025
- Manufacturer
- BECTON, DICKINSON & CO. (BROKEN BOW)
- Product Code
- JSM
- UDI-DI
- 50382903649582
- PMA / PMN Number
- K024240
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY: BD RECEIVED ONE PHOTO FOR INVESTIGATION. THE PHOTO WAS EVALUATED AND DOES NOT SHOW THE CUSTOMER¿S INDICATED FAILURE MODES: PER SPECIFICATION, THIS PRODUCT HAS A MINIMUM FILL LINE AND DOES NOT HAVE A MAXIMUM FILL LINE, THE SPECIMEN IS ABOVE THE MINIMUM FILL LINE; THEREFORE, HAS THE CORRECT DRAW. THE HEMOGARD CLOSURE ASSEMBLY IS INTACT AND ON THE TUBE. ADDITIONALLY,100 RETENTION SAMPLES WERE VISUALLY INSPECTED WITH NO ISSUES OBSERVED. 10 RETENTION SAMPLES WERE FUNCTIONALLY TESTED FOR DRAW VOLUME AND STOPPER FUNCTION WITH ALL TUBES TESTING WITHIN SPECIFICATION REQUIREMENTS. ADDITIONALLY, FACTORS THAT MAY CONTRIBUTE TO STOPPER FUNCTION WERE EVALUATED THROUGH A CLINICAL STUDY TO VERIFY THE DESIGN OF THE DEVICE MET IT¿S INTENDED USE. THE RESULT OF THE STUDY SHOWED THAT THE DEVICE PERFORMED AS EXPECTED AND WE WERE UNABLE TO DETERMINE ANY EXTERNAL CONTRIBUTOR TO THIS REPORTED ISSUE. CUSTOMER RETURN SAMPLES FROM A RELATED PR WERE INCLUDED IN THE STUDY. THE ADDITIONAL TESTING WAS PERFORMED AT FRANKLIN LAKES: BOTH CUSTOMER¿S SAMPLES AND RETAINED SAMPLES FROM LOT# 4043778 EXP AUG 31, 2025 WERE TESTED TO CHARACTERIZE STOPPER PULL-OUT FORCE, AND BOTH SAMPLES PASSED BD PERFORMANCE REQUIREMENTS WITH NO STOPPER SHIELD SEPARATION. 8 CONTAMINATED SAMPLES WERE ALSO SENT FROM THE CUSTOMER, BUT LOT NUMBER CANNOT BE IDENTIFIED DUE TO DOUBLE LABELLING (CUSTOMER¿S LABEL OVER BD LABEL). BD DOES NOT HAVE A PROCEDURE TO TEST CONTAMINATED SAMPLES, SO THESE SAMPLES WERE NOT TESTED. DESIGN OF EXPERIMENTS WERE PERFORMED TO STUDY POTENTIAL FACTORS INFLUENCING THE STOPPER PULL-OUT AT THE CUSTOMER'S SITE. LOT # 3227753 (EXP FEB 28, 2025) AND LOT # 4212945 (EXP JAB 31, 2026) FROM THE CUSTOMER¿S SITE, A FRESH LOT (LOT #4346731 EXP JUN 30, 2026) PULLED FROM BD DISTRIBUTION CENTER AND A COMPETITOR¿S LOT WERE TESTED IN THE STUDY. INVESTIGATION CONCLUSION: BD AND COMPETITOR¿S TUBE HAVE SIMILAR RANGE OF PULLOUT FORCE WHILE BD HAS A TIGHTER CONFIDENCE INTERVAL. LOT # 4212945 HAS A LOWER PULLOUT FORCE, WHILE IT REMAINS WITHIN BD SPECIFICATION. THERE HAVE NOT BEEN ANY OTHER COMPLAINTS ON THIS LOT AS OF APRIL 2, 2025. SLIGHTLY OFF-CENTERED ALIGNMENT AND HIGHER RECAP FORCE FROM THE INSTRUMENT COULD MAKE LOT #4212945 PERFORM SUB-OPTIMALLY. 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 MODES STOPPER FUNCTION/LOOSE STOPPER AND OVERFILL. 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.
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 WHILE USING BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE, AN UNSPECIFIED NUMBER OF TUBES ARE NOT RECAPPING PROPERLY ON THEIR AUTOMATED INSTRUMENT; SOME TUBES EXHIBIT LOOSE CAPS PRIOR TO USE. THOSE TUBES WITH LOOSE CAPS ARE OVERFILLING WHEN USING THE STRAW. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED WHILE USING BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE, AN UNSPECIFIED NUMBER OF TUBES ARE NOT RECAPPING PROPERLY ON THEIR AUTOMATED INSTRUMENT; SOME TUBES EXHIBIT LOOSE CAPS PRIOR TO USE. THOSE TUBES WITH LOOSE CAPS ARE OVERFILLING WHEN USING THE STRAW. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1615027 | BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE | CULTURE MEDIA, NON-PROPAGATING TRANSPORT | JSM | BECTON, DICKINSON & CO. (BROKEN BOW) | 4212945 | 50382903649582 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |