BD EMERALD 10ML STERILE DISPOSABLE GRADUATED CONCENTRIC LUER SLIP SYRINGE
Report
- Report Number
- 3002682307-2022-00173
- Event Type
- Malfunction
- Date Received
- June 23, 2022
- Date of Event
- May 27, 2022
- Report Date
- March 13, 2023
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMF
- 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 IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 307736 AND LOT NUMBER 2202241. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, TWENTY RETAINED SAMPLES WERE OBTAINED FOR EVALUATION; HOWEVER, THE RETAINED SAMPLES DID NOT SHOW ANY SIGNS OF THE REPORTED DEFECT. BASED ON THE INVESTIGATION RESULTS AND THE PROVIDED FEEDBACK, WE ARE UNABLE TO CONFIRM THIS ISSUE AND AN EXACT CAUSE CAN NOT BE DETERMINED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 18-JAN-2023 . H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 307736 AND LOT NUMBER 2202241. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, THE AFFECTED SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE SAMPLE, THE REPORTED ISSUE WAS CONFIRMED. WE WERE ABLE TO IDENTIFY THE DROPLET AS THE SILICONE USED WITH THE STOPPER COMPONENT. TWENTY (20) RETAINED SAMPLES HAD ALSO BEEN OBTAINED FROM THE MANUFACTURING FACILITY AND EVALUATED; HOWEVER, NO ISSUES WERE IDENTIFIED WITH THE RETAINED SAMPLES. THE ORIGIN OF THE ¿DROP OF LIQUID¿ IN THE BARREL WAS SILICONE OIL. SILICONE OIL IS USED TO LUBRICATE THE INNER PART OF THE BARREL AND FACILITATE THE MOVEMENT OF THE PLUNGER ROD. THE CORRECT PRESENCE AND QUANTITY OF SILICONE IN THE SYRINGE IS EVALUATED BY OUR ROUTINE MANUFACTURING CONTROLS. IN THIS EVENT, A TEMPORARY ISSUE WITH THE SILICONIZATION PROCESS COULD HAVE OCCURRED, CAUSING AN EXCESS OF SILICONE AND RESULTING IN THE DEFECTIVE PRODUCT.
IT WAS REPORTED WHILE USING BD EMERALD 10ML STERILE DISPOSABLE GRADUATED CONCENTRIC LUER SLIP SYRINGE FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THIS OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRESENCE OF A DROP OF LIQUID INSIDE A 10ML SYRINGE (NEW SYRINGE TAKEN OUT OF ITS STERILE PACKAGING WHICH WAS INTACT). TAKING A 2ND SYRINGE (OF THE SAME LOT NUMBER), SAME THING, A DROP OF LIQUID ALSO PRESENT INSIDE.
IT WAS REPORTED WHILE USING BD EMERALD 10ML STERILE DISPOSABLE GRADUATED CONCENTRIC LUER SLIP SYRINGE FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THIS OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRESENCE OF A DROP OF LIQUID INSIDE A 10ML SYRINGE (NEW SYRINGE TAKEN OUT OF ITS STERILE PACKAGING WHICH WAS INTACT). TAKING A 2ND SYRINGE (OF THE SAME LOT NUMBER), SAME THING, A DROP OF LIQUID ALSO PRESENT INSIDE.
IT WAS REPORTED WHILE USING BD EMERALD 10ML STERILE DISPOSABLE GRADUATED CONCENTRIC LUER SLIP SYRINGE FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THIS OCCURRED TWICE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRESENCE OF A DROP OF LIQUID INSIDE A 10ML SYRINGE (NEW SYRINGE TAKEN OUT OF ITS STERILE PACKAGING WHICH WAS INTACT). TAKING A 2ND SYRINGE (OF THE SAME LOT NUMBER), SAME THING, A DROP OF LIQUID ALSO PRESENT INSIDE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 257166 | BD EMERALD 10ML STERILE DISPOSABLE GRADUATED CONCENTRIC LUER SLIP SYRINGE | PISTON SYRINGE | FMF | BECTON DICKINSON, S.A. | 2202241 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |