LUER-LOK
Report
- Report Number
- 1213809-2025-00446
- Event Type
- Malfunction
- Date Received
- June 27, 2025
- Date of Event
- May 27, 2025
- Report Date
- July 4, 2025
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 00382903029952
- PMA / PMN Number
- K110771
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
(B)(4) - SUPPLEMENTAL MDR - SILICONE VISIBLE SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. PLEASE NOTE IT IS POSSIBLE THE FM/¿STICKY GEL SUBSTANCE¿ OBSERVED IN THE SYRINGE IS SILICONE. SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS, WITH ESTIMATED DISTRIBUTION WELL IN EXCESS OF 25 BILLION UNITS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
E.1. ADDRESS WAS NOT LOCATED AND IL WAS USED. AS NEITHER A LOT NUMBER NOR A SAMPLE WAS AVAILABLE FOR THIS INCIDENT, A COMPLETE INVESTIGATION COULD NOT BE CONFIRMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. COMPLAINTS RECEIVED WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
(B)(4). FOLLOW-UP REPORT FOR ADDITIONAL INFORMATION. MW5171050 WAS RECEIVED THROUGH THE FDA¿S MEDWATCH PROGRAM.
(B)(4). FOLLOW-UP REPORT FOR ADDITIONAL INFORMATION. MW5171050 WAS RECEIVED THROUGH THE FDA¿S MEDWATCH PROGRAM.
NO ADDITIONAL INFORMATION WAS PROVIDED.
IT WAS REPORTED THAT THE BD SYRINGE 10ML LL S/C 200 HAD VISIBLE SILICONE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 302995, LOT#: 5093968, UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT 10 ML UNOPENED IV SYRINGES FOR IV COMPOUNDING WERE FOUND TO HAVE A VISCOUS FILM ON THE PLUNGER SEAL. IT APPEARS AS IF THE LUBRICANT THAT IS SUPPOSED TO BE AROUND THE CIRCUMFERENCE OF THE PLUNGER SEAL HAD MIGRATED INTO THE SPACE WHERE DRUG IS CONTAINED, POSING A RISK FOR CONTAMINATION. RCC RECEIVED A COMPLAINT VIA EMAIL. 10 ML UNOPENED IV SYRINGES FOR IV COMPOUNDING WERE FOUND TO HAVE A VISCOUS FILM ON THE PLUNGER SEAL. IT APPEARS AS IF THE LUBRICANT THAT IS SUPPOSED TO BE AROUND THE CIRCUMFERENCE OF THE PLUNGER SEAL. HAD MIGRATED INTO THE SPACE WHERE DRUG IS CONTAINED, POSING A RISK FOR CONTAMINATION.
MW5171050 WAS RECEIVED THROUGH THE FDA'S MEDWATCH PROGRAM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 939055 | LUER-LOK | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 5093968 | 00382903029952 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |