1920898-2018-00457
Report
- Report Number
- 1920898-2018-00457
- Event Type
- Malfunction
- Date Received
- June 29, 2018
- Date of Event
- June 11, 2018
- Report Date
- July 13, 2018
- PMA / PMN Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- PATIENT
Narratives
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
INVESTIGATION SUMMARY: CUSTOMER RETURNED A PHOTO OF A 1/2CC SYRINGE IN A BLISTER PACK. CUSTOMER STATES THAT ONE SYRINGE DOES NOT HAVE A STOPPER. THE ATTACHED PHOTO WAS EXAMINED AND EXHIBITED A MISSING STOPPER IN THE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 7121534. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION (B)(4) NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: -CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE INVESTIGATION CONCLUSION: AT THE STOPPER ASSEMBLY ON THE METRO MACHINE AS THE DIAL FOR THE PLUNGER COMES AROUND FOR THE MARRIAGE OF THE STOPPER TO PLUNGER, A PLUNGER COULD GET HUNG UP IN THE DIAL AND NOT ALLOW THE STOPPER TO ASSEMBLE TO THE PLUNGER.
IT WAS REPORTED THAT A BD ULTRA-FINE¿ INSULIN SYRINGE WAS MISSING A STOPPER. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.
IT WAS REPORTED THAT A BD ULTRA-FINE¿ INSULIN SYRINGE WAS MISSING A STOPPER. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |