BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
Report
- Report Number
- 1024879-2022-00007
- Event Type
- Malfunction
- Date Received
- January 18, 2022
- Date of Event
- December 27, 2021
- Report Date
- February 7, 2022
- Manufacturer
- BECTON, DICKINSON & CO., (BD)
- Product Code
- JKA
- UDI-DI
- 00382903673643
- PMA / PMN Number
- K153309
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPES ARE AS FOLLOWS. MEDICAL DEVICE TYPE: JKA / FPA. COMMON DEVICE NAME: BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET THERE WAS ANOTHER UNKNOWN LOT NUMBER MENTIONED. THE UNKNOWN INFORMATION FOR THE UNKNOWN LOT NUMBER IS CAPTURED BELOW: MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THERE WERE MULTIPLE DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPES ARE AS FOLLOWS. MEDICAL DEVICE TYPE: JKA / FPA. COMMON DEVICE NAME: BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET THERE WAS ANOTHER UNKNOWN LOT NUMBER MENTIONED. THE UNKNOWN INFORMATION FOR THE UNKNOWN LOT NUMBER IS CAPTURED BELOW: MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 1/31/2022. H.6. INVESTIGATION: BD RECEIVED 8 PHOTOS AND 2 PHYSICAL SAMPLES FROM THE CUSTOMER IN SUPPORT OF THIS INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER¿ S INDICATED FAILURE MODES OF FOREIGN MATTER AND SPRING POP OUT WAS OBSERVED. THE EVALUATION OF THE SAMPLE REVEALED UNUSED BD PUSH BUTTON BLOOD COLLECTION NEEDLE WITH THE SPRING OUTSIDE THE HOUSING BARRELS. SPECIFICALLY, THE SPRING WAS WOUND AROUND THE IV PROTECTOR. ADDITIONALLY, THERE IS AN UNUSED BD PUSH BUTTON BLOOD COLLECTION NEEDLE WITH EMBEDDED FOREIGN MATTER IN THE WINGS. THEREFORE, THIS COMPLAINT IS CONFIRMED BASED ON CUSTOMER SAMPLES AND PHOTOS RECEIVED. THE DEVICE HISTORY RECORD FOR BATCH 1231017 WAS REVIEWED WITH NOD ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED FOR THE SECOND BATCH AS THE BATCH NUMBER IS UNKNOWN. ADDITIONALLY, 100 RETENTION SAMPLES FOR BATCH 1231017 WERE SUBJECTED TO A VISUAL INSPECTION FOR A SPRING POP OUT DEFECT. ALL SAMPLES PASSED THE TEST WITH NO DEFECTS OBSERVED. BD WAS ABLE TO CONFIRM THE CUSTOMER COMPLAINT OF SPRING POP-OUT. THE ROOT CAUSE IS ATTRIBUTED TO THE ASSEMBLY PROCESS AND, FURTHER PROCESSING OF THE PART OCCURRED WITH INADEQUATE PURGING OF THE PART. AWARENESS OF THIS COMPLAINT HAS BEEN CREATED WITHIN THE ENGINEERING DEPARTMENT AND THE BUSINESS TEAM. BD IS ABLE TO DUPLICATE/CONFIRM THE CUSTOMER¿S REPORTED FAILURE OF EMBEDDED FOREIGN MATTER ON THE WING FROM THE CUSTOMER SAMPLE AND PHOTO RECEIVED. THE FOREIGN MATTER ON THE WING WAS FOUND TO BE EMBEDDED AND, THE ROOT CAUSE OF THE DISCOLORED WING IS ATTRIBUTED TO THE MANUFACTURING PROCESS.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE DEVICE WAS BROKEN, DAMAGED, AND UNASSEMBLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE CUSTOMER REPORTED THE FOLLOWING TWO ISSUES OF WINGSET UTPBBCS: LOT#: UNKNOWN; BLACK FM WAS VISUALLY CLEARLY OBSERVED. LOT#: 1231017; THE SPRING WAS FOUND TO BE POPPING OUT BEFORE USE.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE DEVICE WAS BROKEN, DAMAGED, AND UNASSEMBLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE CUSTOMER REPORTED THE FOLLOWING TWO ISSUES OF WINGSET UTPBBCS: LOT#: UNKNOWN; BLACK FM WAS VISUALLY CLEARLY OBSERVED. LOT#: 1231017; THE SPRING WAS FOUND TO BE POPPING OUT BEFORE USE.
IT WAS REPORTED WHEN USING THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET, THE DEVICE WAS BROKEN, DAMAGED, AND UNASSEMBLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE CUSTOMER REPORTED THE FOLLOWING TWO ISSUES OF WINGSET UTPBBCS: (1)LOT#: UNKNOWN; BLACK FM WAS VISUALLY CLEARLY OBSERVED. (2)LOT#: 1231017; THE SPRING WAS FOUND TO BE POPPING OUT BEFORE USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 164099 | BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO., (BD) | 1231017 | 00382903673643 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |