BD SYRINGE 30ML LL S/C 56
Report
- Report Number
- 1911916-2021-01151
- Event Type
- Malfunction
- Date Received
- November 9, 2021
- Date of Event
- October 12, 2021
- Report Date
- December 7, 2021
- Manufacturer
- BD MEDICAL (BD WEST) MEDICAL SURGICAL
- Product Code
- FMF
- UDI-DI
- 00382903028320
- PMA / PMN Number
- K110771
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 10/25/2021. H.6. INVESTIGATION: IT WAS REPORTED A TINY PIECE OF PLASTIC WAS INSIDE THE SYRINGE. TO AID IN THE INVESTIGATION, ONE SAMPLE AND TWO PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED WITH A 10X MAGNIFIER LENS AND AT THE BOTTOM OF THE SYRINGE THERE IS A PIECE OF PLASTIC. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE TWO PHOTOS PROVIDED SHOW THE BOTTOM PART OF A SYRINGE WHERE THERE IS A WHITE FOREIGN MATTER INDICATED WITH AN ARROW. THIS DEFECT COULD OCCUR DURING THE ASSEMBLY PROCESS IF A PART BECAME DAMAGED AND A PIECE OF PLASTIC ENDED UP IN THE SYRINGE BARREL. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOT NUMBER 0113855 . THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF THE ASSEMBLY PROCESS WAS PERFORMED. THE ALIGNMENT OF FIXTURES AND PARTS WERE CORRECT. NO JAMS WERE OBSERVED. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. H3 OTHER TEXT : SEE H.10.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: IT WAS REPORTED A TINY PIECE OF PLASTIC WAS INSIDE THE SYRINGE. TO AID IN THE INVESTIGATION, ONE SAMPLE AND TWO PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED WITH A 10X MAGNIFIER LENS AND AT THE BOTTOM OF THE SYRINGE THERE IS A PIECE OF PLASTIC. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE TWO PHOTOS PROVIDED SHOW THE BOTTOM PART OF A SYRINGE WHERE THERE IS A WHITE FOREIGN MATTER INDICATED WITH AN ARROW. THIS DEFECT COULD OCCUR DURING THE ASSEMBLY PROCESS IF A PART BECAME DAMAGED AND A PIECE OF PLASTIC ENDED UP IN THE SYRINGE BARREL. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOT NUMBER 0113855. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF THE ASSEMBLY PROCESS WAS PERFORMED. THE ALIGNMENT OF FIXTURES AND PARTS WERE CORRECT. NO JAMS WERE OBSERVED. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: IT WAS REPORTED A TINY PIECE OF PLASTIC WAS INSIDE THE SYRINGE. TO AID IN THE INVESTIGATION, ONE SAMPLE AND TWO PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED WITH A 10X MAGNIFIER LENS AND AT THE BOTTOM OF THE SYRINGE THERE IS A PIECE OF PLASTIC. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE TWO PHOTOS PROVIDED SHOW THE BOTTOM PART OF A SYRINGE WHERE THERE IS A WHITE FOREIGN MATTER INDICATED WITH AN ARROW. THIS DEFECT COULD OCCUR DURING THE ASSEMBLY PROCESS IF A PART BECAME DAMAGED AND A PIECE OF PLASTIC ENDED UP IN THE SYRINGE BARREL. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOT NUMBER 0113855. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. VERIFICATION OF THE ASSEMBLY PROCESS WAS PERFORMED. THE ALIGNMENT OF FIXTURES AND PARTS WERE CORRECT. NO JAMS WERE OBSERVED. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.
IT WAS REPORTED THAT BD SYRINGE 30ML LL S/C 56 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A TINY PIECE OF PLASTIC WAS INSIDE THE 30ML SYRINGE LUER LOCK TIP. VERBATIM: DURING USE, IT WAS DISCOVERED THAT A TINY PIECE OF PLASTIC IS INSIDE THE 30ML SYRINGE LUER LOCK TIP. THERE WAS NO TYPE OF CUSTOMER OR PATIENT HARM AND THE SYRINGE WAS DISCARDED.
IT WAS REPORTED THAT BD SYRINGE 30ML LL S/C 56 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A TINY PIECE OF PLASTIC WAS INSIDE THE 30ML SYRINGE LUER LOCK TIP. VERBATIM: DURING USE, IT WAS DISCOVERED THAT A TINY PIECE OF PLASTIC IS INSIDE THE 30ML SYRINGE LUER LOCK TIP. THERE WAS NO TYPE OF CUSTOMER OR PATIENT HARM AND THE SYRINGE WAS DISCARDED.
IT WAS REPORTED THAT BD SYRINGE 30ML LL S/C 56 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A TINY PIECE OF PLASTIC WAS INSIDE THE 30ML SYRINGE LUER LOCK TIP. VERBATIM: DURING USE, IT WAS DISCOVERED THAT A TINY PIECE OF PLASTIC IS INSIDE THE 30ML SYRINGE LUER LOCK TIP. THERE WAS NO TYPE OF CUSTOMER OR PATIENT HARM AND THE SYRINGE WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1678967 | BD SYRINGE 30ML LL S/C 56 | PISTON SYRINGE | FMF | BD MEDICAL (BD WEST) MEDICAL SURGICAL | 0113855 | 00382903028320 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |