BD PLASTIPAK¿ 3ML SYRINGE
Report
- Report Number
- 1213809-2022-00587
- Event Type
- Malfunction
- Date Received
- September 17, 2022
- Date of Event
- July 16, 2022
- Report Date
- November 2, 2022
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 00382903096572
- PMA / PMN Number
- K182589
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 25-OCT-2022. H6: INVESTIGATION SUMMARY: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT AN OILY RESIDUE WAS PRESENT ON THE STOPPER WHICH APPEARED TO BE SILICONE LUBRICANT USED IN THE ASSEMBLY PROCESS. THE AMOUNT OBSERVED WAS WITHIN THE NORMAL LIMITS AND THE SAMPLE WAS ACCEPTABLE PER PRODUCT SPECIFICATION. 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1111005. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.
H6: INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1111005. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. PLEASE NOTE THAT THE ¿OILY SUBSTANCE¿ OBSERVED IN THE SYRINGE IS MOST LIKELY SILICONE. SILICONE IS A VITAL COMPONENT OF THE MANUFACTURING PROCESS, AND ALLOWS FOR THE PISTON TO GLIDE INSIDE OF THE SYRINGE, IT IS A SAFE AND COMMONLY USED COMPONENT IN THE MEDICAL DEVICE INDUSTRY. SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY.
IT WAS REPORTED WHILE USING BD PLASTIPAK¿ 3ML SYRINGE THERE WAS FOREIGN MATTER IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS THAT THERE IS AN OILY RESIDUE IN THE SYRINGE BARREL.
IT WAS REPORTED WHILE USING BD PLASTIPAK¿ 3ML SYRINGE THERE WAS FOREIGN MATTER IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS THAT THERE IS AN OILY RESIDUE IN THE SYRINGE BARREL.
IT WAS REPORTED WHILE USING BD PLASTIPAK¿ 3ML SYRINGE THERE WAS FOREIGN MATTER IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS THAT THERE IS AN OILY RESIDUE IN THE SYRINGE BARREL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 223250 | BD PLASTIPAK¿ 3ML SYRINGE | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 1111005 | 00382903096572 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |