BD¿ 20 ML SYRINGE WITH NEEDLE
Report
- Report Number
- 3002682307-2021-00659
- Event Type
- Malfunction
- Date Received
- December 16, 2021
- Date of Event
- July 20, 2021
- Report Date
- March 9, 2022
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMF
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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.
H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301948 AND LOT NUMBER 2101172. THE REVIEW ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY AND NO ABNORMALITIES OR QUALITY NOTIFICATIONS RELATED TO THIS REPORTED INCIDENT WERE IDENTIFIED. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY RETAINED SAMPLES WERE OBTAINED FOR FURTHER EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE RETAINED SAMPLES, NO SIGNS OF DEFECT COULD BE IDENTIFIED. BASED ON THE LIMITED INVESTIGATION RESULTS, AN EXACT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.
IT WAS REPORTED WHEN USING THE BD¿ 20 ML SYRINGE WITH NEEDLE, THE DEVICE EXPERIENCED DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE PLUNGER WAS DIFFICULT BOLUS DURING USE.
IT WAS REPORTED WHEN USING THE BD¿ 20 ML SYRINGE WITH NEEDLE, THE DEVICE EXPERIENCED DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE PLUNGER WAS DIFFICULT BOLUS DURING USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1920881 | BD¿ 20 ML SYRINGE WITH NEEDLE | PISTON SYRINGE | FMF | BECTON DICKINSON, S.A. | 2101172 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |