BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE
Report
- Report Number
- 2243072-2023-00264
- Event Type
- Malfunction
- Date Received
- February 27, 2023
- Date of Event
- December 14, 2022
- Report Date
- September 26, 2023
- Manufacturer
- BECTON, DICKINSON & CO. (BROKEN BOW)
- Product Code
- JSM
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MB
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
THE FOLLOWING FIELDS HAVE BEEN UPDATED: SITE LEGAL NAME: BECTON DICKINSON & CO - BROKEN BOW, NE 68822. B5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHEN USING THE BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "GLASS CONTAMINATED AFTER THE USE." D1: MEDICAL DEVICE BRAND NAME: BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE. D2A: COMMON DEVICE NAME: TRANSPORT CULTURE MEDIUM. D2B: MEDICAL DEVICE TYPE: JSM. D3: MEDICAL DEVICE MANUFACTURER: BECTON, DICKINSON & CO. (BROKEN BOW). D4: CATALOG: 364955. D4: LOT# 2125687. D4: EXP DATE: 30-NOV-2023. D4:UDI: (B)(4). G1: MANUFACTURING LOCATION: BECTON, DICKINSON & CO. (BROKEN BOW).
H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 4 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER WAS OBSERVED. 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 FOREIGN MATTER. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.
IT WAS REPORTED WHEN USING THE RACK BD VACUTAINER Z365000 & 364955 THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "GLASS CONTAMINATED AFTER THE USE."
IT WAS REPORTED WHEN USING THE BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "GLASS CONTAMINATED AFTER THE USE."
IT WAS REPORTED WHEN USING THE RACK BD VACUTAINER Z365000 & 364955 THERE WAS FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "GLASS CONTAMINATED AFTER THE USE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2287873 | BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE | TRANSPORT CULTURE MEDIUM | JSM | BECTON, DICKINSON & CO. (BROKEN BOW) | 2125687 | ||
| 753159 | BD VACUTAINER® BORIC ACID SODIUM BORATE/FORMATE C&S URINE TUBE | TRANSPORT CULTURE MEDIUM | JSM | BECTON, DICKINSON & CO. (BROKEN BOW) | 2125687 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |