BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE
Report
- Report Number
- 1213809-2021-00839
- Event Type
- Malfunction
- Date Received
- January 5, 2022
- Date of Event
- December 3, 2021
- Report Date
- January 6, 2022
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 30382903095972
- PMA / PMN Number
- K110771
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
INVESTIGATION SUMMARY: TWO PHOTOS WERE RECEIVED AND EVALUATED. ONE PHOTO DISPLAYED THE GRAPHIC SIDE OF A BLISTER PACKAGE (P/N 309597) FROM BATCH #0150719. THE SECOND PHOTO DISPLAYED A 1ML SYRINGE WITH NEEDLE IN ITS BLISTER PACKAGE WITH NEEDLE ATTACHED. AN ARROW POINTING TO THE NEEDLE/TIP CONNECTION WAS PRESENT. THE CONNECTION DID NOT APPEAR TO BE IRREGULAR FROM THE PHOTO AND NO NON-CONFORMITIES WERE OBSERVED. UNUSED PHYSICAL SAMPLES ARE NEEDED TO PERFORM A MORE IN-DEPTH EVALUATION. SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED THAT THE BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE SEPARATED FROM ITS MATING COMPONENT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT POPPED APART RIGHT THERE AND I ALWAYS TRY TO TIGHTEN WITH A LITTLE PUSH BEFORE I PULL THE DOSAGE".
IT WAS REPORTED THAT THE BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE SEPARATED FROM ITS MATING COMPONENT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT POPPED APART RIGHT THERE AND I ALWAYS TRY TO TIGHTEN WITH A LITTLE PUSH BEFORE I PULL THE DOSAGE".
IT WAS REPORTED THAT THE BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE SEPARATED FROM ITS MATING COMPONENT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT POPPED APART RIGHT THERE AND I ALWAYS TRY TO TIGHTEN WITH A LITTLE PUSH BEFORE I PULL THE DOSAGE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1158771 | BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 309597 | 0150719 | 30382903095972 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |