BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
Report
- Report Number
- 1710034-2023-00358
- Event Type
- Malfunction
- Date Received
- April 4, 2023
- Date of Event
- March 14, 2023
- Report Date
- June 1, 2023
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- JKA
- UDI-DI
- 50382903673242
- PMA / PMN Number
- K030573
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 2131350, D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2024, D.10 DEVICE AVAILABLE FOR EVAL? YES, D.10 RETURNED TO MANUFACTURER ON: 3-APR-2023, H.2 DEVICE RETURN TO MANUF .?: YES, H.4. DEVICE MANUFACTURE DATE: 02-JUN-2022.
H.6. INVESTIGATION SUMMARY: BD RECEIVED ONE SAMPLE AND 6 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR UNIDENTIFIED MATERIAL WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLE WAS EVALUATED BY VISUAL EXAMINATION AND MATERIAL ANALYSIS AND THE INDICATED FAILURE MODE FOR UNIDENTIFIED MATERIAL WITH THE INCIDENT LOT 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 OF UNIDENTIFIED MATERIAL. THE RETURNED PUSH BUTTON BLOOD COLLECTION SET (PBBCS) CONTAINED EMBEDDED MATERIAL IN THE TUBING THAT WAS DETERMINED TO BE CLUMPS OF TUBING MATERIAL THAT WAS LIKELY INTRODUCED DURING EXTRUSION.
THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: MEDICAL DEVICE TYPE: FPA. COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET. 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.
IT WAS REPORTED THAT PRIOR TO USE WITH BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET FOREIGN MATTER WAS DISCOVERED IN THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: ACCORDING TO THE CUSTOMER'S REPORT, FM WAS FOUND IN THE TUBING BEFORE USAGE.
IT WAS REPORTED THAT PRIOR TO USE WITH BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET FOREIGN MATTER WAS DISCOVERED IN THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: ACCORDING TO THE CUSTOMER'S REPORT, FM WAS FOUND IN THE TUBING BEFORE USAGE.
IT WAS REPORTED THAT PRIOR TO USE WITH BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET FOREIGN MATTER WAS DISCOVERED IN THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: ACCORDING TO THE CUSTOMER'S REPORT, FM WAS FOUND IN THE TUBING BEFORE USAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 382616 | BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 367324 | 2131350 | 50382903673242 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |