BD 30GA 1/2IN NEEDLE
Report
- Report Number
- 3002682307-2021-00645
- Event Type
- Malfunction
- Date Received
- December 10, 2021
- Date of Event
- November 12, 2021
- Report Date
- January 11, 2022
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMI
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 LOT NUMBER 210335. 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. AS SAMPLES WERE UNAVAILABLE FOR RETURN, RETAINED SAMPLES WERE OBTAINED FOR FURTHER EVALUATION BY OUR QUALITY ENGINEER TEAM. THE RETAINED SAMPLES WERE ASSEMBLED TO A CAVERJET SYRINGE PROVIDED BY THE CUSTOMER IN THE PAST. THE NEEDLES WERE ASSEMBLED BY FOLLOWING THE INSTRUCTIONS OF THE CAVERJET KIT. THE HUB WAS POSITIONED ONTO THE SYRINGE TIP WITH A SLIGHTLY ROTATIONAL MOVEMENT. NONE OF THE SAMPLES PRESENTED ANY SIGN OF DEFECT DURING THE CONNECTION. THE ASSEMBLED SAMPLES DISPLAYED NO SIGNS OF LEAKAGE OR CLOGGED NEEDLES. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THESE ISSUES. IT IS POSSIBLE THAT THE REPORTED LEAKAGE RESULTED FROM DEFECTIVE LUER DIMENSIONS, DAMAGE TO THE SYRINGE TIP, OR AN INSUFFICIENT ADJUSTMENT MADE BETWEEN THE TWO DEVICES IN THE USER ENVIRONMENT. DURING THE CANNULA ASSEMBLY PROCESS, NEEDLES ARE INSPECTED THROUGH USE OF A CAMERA SYSTEM. THE CAMERA SENSES A LIGHT SOURCE POSITIONED ON THE OPPOSITE END OF THE NEEDLE. IF THE CAMERA DOES NOT SENSE THE LIGHT SOURCE, AN OCCLUSION MAY BE PRESENT AND THE NEEDLE IS AUTOMATICALLY REJECTED. ADDITIONAL INSPECTIONS FOR OCCLUSION ARE ALSO COMPLETED AFTER ASSEMBLY AND PRIOR TO THE RELEASE OF EACH LOT MANUFACTURED. IN CERTAIN CIRCUMSTANCES, THE DRUG USED CAN BECOME DEPOSITED WITHIN THE CANNULA, CAUSING THE NEEDLE TO BLOCK DUE TO CRYSTALLIZATION. OCCLUSION IS MOST LIKELY TO OCCUR IF THE DRUG REMAINS IN THE NEEDLE FOR AN EXTENDED PERIOD OF TIME. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CLOSELY MONITOR THE PRODUCTION PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED THAT THE BD 30GA 1/2IN NEEDLE EXPERIENCED LEAKAGE, AND WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT THE TIME OF APPLICATION, THERE WAS A LEAK IN THE NEEDLE FITTING AND IT SEEMED THAT THE NEEDLE WAS CLOGGED.
IT WAS REPORTED THAT THE BD 30GA 1/2IN NEEDLE EXPERIENCED LEAKAGE, AND WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT THE TIME OF APPLICATION, THERE WAS A LEAK IN THE NEEDLE FITTING AND IT SEEMED THAT THE NEEDLE WAS CLOGGED.
IT WAS REPORTED THAT THE BD 30GA 1/2IN NEEDLE EXPERIENCED LEAKAGE, AND WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT THE TIME OF APPLICATION, THERE WAS A LEAK IN THE NEEDLE FITTING AND IT SEEMED THAT THE NEEDLE WAS CLOGGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1872556 | BD 30GA 1/2IN NEEDLE | NEEDLE | FMI | BECTON DICKINSON, S.A. | 210335 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |