BD MICROLANCE¿ 3 NEEDLES
Report
- Report Number
- 3002682307-2022-00056
- Event Type
- Malfunction
- Date Received
- February 16, 2022
- Date of Event
- December 1, 2021
- Report Date
- April 14, 2022
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMI
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 08-MAR-2022. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304432 AND LOT NUMBER 210728. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, NINE SHELF CARTONS OF NEEDLE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. TWENTY SAMPLES WERE RANDOMLY SELECTED FOR THOROUGH ANALYSIS. THE SAMPLES WERE ASSEMBLED WITH A BD EMERALD SYRINGE BY FOLLOWING REGULAR PRACTICES; THE HUB WAS POSITIONED ONTO THE SYRINGE TIP WITH A SLIGHTLY ROTATIONAL MOVEMENT. NO DEFECTS WERE IDENTIFIED WITH THE CONNECTION PROCESS. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS REPORTED INCIDENT. WE UNDERSTAND THAT A DEFECTIVE HUB CONNECTION ISSUE TOOK PLACE, BASED ON THE PROVIDED FEEDBACK. IT IS POSSIBLE THAT THIS ISSUE RESULTED FROM DEFECTIVE LUER DIMENSIONS, DAMAGE TO THE SYRINGE TIP, OR AN INSUFFICIENT ADJUSTMENT BETWEEN THE DEVICES.
IT WAS REPORTED THAT THE NEEDLE SEPARATED FROM THE SYRINGE AND LEAKED WHILE USING BD MICROLANCE¿ 3 NEEDLES. THE PATIENT DID NOT RECEIVE FULL DOSE OF MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE HAS COME AWAY FROM SYRINGE WHILST INJECTION PATIENT WITH DEPO INJECTION, CAUSING CONTENTS TO SPILL AND UNKNOWN DOSE DELIVERED.
IT WAS REPORTED THAT THE NEEDLE SEPARATED FROM THE SYRINGE AND LEAKED WHILE USING BD MICROLANCE¿ 3 NEEDLES. THE PATIENT DID NOT RECEIVE FULL DOSE OF MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE HAS COME AWAY FROM SYRINGE WHILST INJECTION PATIENT WITH DEPO INJECTION, CAUSING CONTENTS TO SPILL AND UNKNOWN DOSE DELIVERED.
IT WAS REPORTED THAT THE NEEDLE SEPARATED FROM THE SYRINGE AND LEAKED WHILE USING BD MICROLANCE¿ 3 NEEDLES. THE PATIENT DID NOT RECEIVE FULL DOSE OF MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE HAS COME AWAY FROM SYRINGE WHILST INJECTION PATIENT WITH DEPO INJECTION, CAUSING CONTENTS TO SPILL AND UNKNOWN DOSE DELIVERED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2282504 | BD MICROLANCE¿ 3 NEEDLES | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON, S.A. | 210728 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |