BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER
Report
- Report Number
- 1024879-2022-00218
- Event Type
- Malfunction
- Date Received
- April 14, 2022
- Date of Event
- April 1, 2022
- Report Date
- August 11, 2022
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- PMA / PMN Number
- K991088
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: B5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHEN USING THE BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER, THE DEVICE EXPERIENCED THE NON-PATIENT NEEDLE SEPARATING FROM THE HOLDER. THIS EVENT OCCURRED ELEVEN TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE LUER ADAPTER FITS LOOSELY ON THE NON-RETURN VALVE OF THE CATHETER USED IN THE ER, THE CATHETER IS BRAUM BRAND. D.4. MEDICAL DEVICE LOT #: 1252106. D.4 MEDICAL DEVICE EXPIRATION DATE: 2024-08-31. H.4. DEVICE MANUFACTURE DATE: 2021-09-09.
RETURNED TO MANUFACTURER ON: 2022-08-11. BD RECEIVED (B)(4) SAMPLES AND A PHOTO FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR LOOSE FIT WITH THE INCIDENT LOT WAS NOT OBSERVED. THE PHOTO SHOWED A LUER ADAPTER DEVICE THAT WAS UNOPENED AND UNUSUED. ADDITIONALLY, THE CUSTOMER SAMPLES WERE EVALUATED BY FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE FOR LOOSE FIT WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. 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 MODE OF LOOSE FIT. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS."
IT WAS REPORTED WHEN USING THE BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER, THE DEVICE EXPERIENCED THE NON-PATIENT NEEDLE SEPARATING FROM THE HOLDER. THIS EVENT OCCURRED TEN TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE LUER ADAPTER FITS LOOSELY ON THE NON-RETURN VALVE OF THE CATHETER USED IN THE ER, THE CATHETER IS BRAUM BRAND.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER, THE DEVICE EXPERIENCED THE NON-PATIENT NEEDLE SEPARATING FROM THE HOLDER. THIS EVENT OCCURRED ELEVEN TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE LUER ADAPTER FITS LOOSELY ON THE NON-RETURN VALVE OF THE CATHETER USED IN THE ER, THE CATHETER IS BRAUM BRAND.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER, THE DEVICE EXPERIENCED THE NON-PATIENT NEEDLE SEPARATING FROM THE HOLDER. THIS EVENT OCCURRED TEN TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE LUER ADAPTER FITS LOOSELY ON THE NON-RETURN VALVE OF THE CATHETER USED IN THE ER, THE CATHETER IS BRAUM BRAND.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 210089 | BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO., (BD) | 1252106 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |