BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE
Report
- Report Number
- 9617032-2022-01103
- Event Type
- Malfunction
- Date Received
- November 6, 2022
- Date of Event
- September 26, 2022
- Report Date
- January 3, 2024
- Manufacturer
- BECTON, DICKINSON AND COMPANY (BD)
- Product Code
- JKA
- PMA / PMN Number
- K022426
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO DAMAGED IV SHIELD AS ALL SAMPLES MET SPECIFICATIONS. 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 DAMAGED IV SHIELD. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE 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."
THE FOLLOWING FIELDS HAVE BEEN UPDATED: 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. IMDRF ANNEX B GRID (1): B15 - ANALYSIS OF DATA PROVIDED BY USER/THIRD PARTY IMDRF ANNEX C GRID (1): C13 - OPERATIONAL PROBLEM IDENTIFIED IMDRF ANNEX D GRID (1): D15 - CAUSE NOT ESTABLISHED H.6. INVESTIGATION SUMMARY: "MATERIAL #: (B)(4) LOT/BATCH #: 2091549 BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR DAMAGED IV SHIELD WAS OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF DAMAGED IV SHIELD WAS NOT 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 DAMAGED IV SHIELD. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED WHEN USING THE BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE FOUND THAT THE PROTECTIVE CAP OF THE NEEDLE OF THE ARTERIAL BLOOD SAMPLER WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: DURING THE PROCESS, IT WAS FOUND THAT THE PROTECTIVE CAP OF THE NEEDLE OF THE ARTERIAL BLOOD SAMPLER WAS DAMAGED, AND THE OTHER ARTERIAL BLOOD SAMPLER WAS IMMEDIATELY REPLACED WITHOUT CAUSING ANY HARM TO THE PATIENT.¿
IT WAS REPORTED WHEN USING THE BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE FOUND THAT THE PROTECTIVE CAP OF THE NEEDLE OF THE ARTERIAL BLOOD SAMPLER WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: DURING THE PROCESS, IT WAS FOUND THAT THE PROTECTIVE CAP OF THE NEEDLE OF THE ARTERIAL BLOOD SAMPLER WAS DAMAGED, AND THE OTHER ARTERIAL BLOOD SAMPLER WAS IMMEDIATELY REPLACED WITHOUT CAUSING ANY HARM TO THE PATIENT.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2853788 | BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON AND COMPANY (BD) | 2091549 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |