BD ECLIPSE HYPODERMIC NEEDLE WITH PROTECTION DEVICE
Report
- Report Number
- 3002682307-2021-00682
- Event Type
- Malfunction
- Date Received
- January 10, 2022
- Date of Event
- November 4, 2021
- Report Date
- February 22, 2022
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMI
- PMA / PMN Number
- K100209
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
INVESTIGATION SUMMARY AS A LOT NUMBER WAS UNKNOWN FOR THIS INCIDENT AND A SAMPLE WAS UNAVAILABLE, NEITHER A PRODUCTION HISTORY REVIEW NOR A THOROUGH SAMPLE ANALYSIS COULD BE COMPLETED BY OUR QUALITY ENGINEER TEAM. BASED ON THE CURRENT INVESTIGATION RESULTS, AN EXACT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.
CORRECTION; H6: IMDRF ANNEX A GRID: A1206 - MISCONNECTION.
MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT BD ECLIPSE HYPODERMIC NEEDLE WITH PROTECTION DEVICE WAS DIFFICULT TO CONNECT TO THE MATING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE-SYRINGE MISMATCH AFTER ADMINISTRATION, WHEN SECURING THE NEEDLE. NEEDLE DROPPED UNSECURED ON CAREGIVER'S FOOT (NO SEA). NO CLINICAL CONSEQUENCES. "
IT WAS REPORTED THAT BD ECLIPSE HYPODERMIC NEEDLE WITH PROTECTION DEVICE WAS DIFFICULT TO CONNECT TO THE MATING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE-SYRINGE MISMATCH AFTER ADMINISTRATION, WHEN SECURING THE NEEDLE. NEEDLE DROPPED UNSECURED ON CAREGIVER'S FOOT (NO SEA). NO CLINICAL CONSEQUENCES. "
IT WAS REPORTED THAT BD ECLIPSE HYPODERMIC NEEDLE WITH PROTECTION DEVICE WAS DIFFICULT TO CONNECT TO THE MATING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE-SYRINGE MISMATCH AFTER ADMINISTRATION, WHEN SECURING THE NEEDLE. NEEDLE DROPPED UNSECURED ON CAREGIVER'S FOOT (NO SEA). NO CLINICAL CONSEQUENCES. "
IT WAS REPORTED THAT BD ECLIPSE HYPODERMIC NEEDLE WITH PROTECTION DEVICE WAS DIFFICULT TO CONNECT TO THE MATING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NEEDLE-SYRINGE MISMATCH AFTER ADMINISTRATION, WHEN SECURING THE NEEDLE. NEEDLE DROPPED UNSECURED ON CAREGIVER'S FOOT (NO SEA). NO CLINICAL CONSEQUENCES. "
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1169145 | BD ECLIPSE HYPODERMIC NEEDLE WITH PROTECTION DEVICE | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON, S.A. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |