BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE
Report
- Report Number
- 1917413-2025-00189
- Event Type
- Malfunction
- Date Received
- February 28, 2025
- Date of Event
- January 31, 2025
- Report Date
- June 27, 2025
- Manufacturer
- BECTON, DICKINSON & CO. (BROKEN BOW)
- Product Code
- JSM
- 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
D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. 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.
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: 13-FEB-2025. INVESTIGATION SUMMARY : BD RECEIVED CONTAMINATED SAMPLES. THE SAMPLES COULD NOT BE EVALUATED AND BD WAS UNABLE TO DETERMINE THE LOT NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED AS LOT NUMBER WAS UNKNOWN. 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. THE ADDITIONAL TESTING WAS PERFORMED AT FRANKLIN LAKES USING RETURNED SAMPLES FROM A RELATED COMPLAINT FROM THIS CUSTOMER AND RETAINED SAMPLES FOR THIS MATERIAL: 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 JAN 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. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE CUSTOMERS 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.
IT WAS REPORTED WHILE USING BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE, AN UNSPECIFIED NUMBER OF TUBES HAVE LOOSE STOPPERS AFTER CAPPING AND RECAPPING THE TUBE. 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 HAVE LOOSE STOPPERS AFTER CAPPING AND RECAPPING THE TUBE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 558713 | BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE | CULTURE MEDIA, NON-PROPAGATING TRANSPORT | JSM | BECTON, DICKINSON & CO. (BROKEN BOW) | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |