BD PLASTIPAK¿ - 3-PIECE SYRINGE
Report
- Report Number
- 3003152976-2022-00173
- Event Type
- Malfunction
- Date Received
- April 27, 2022
- Date of Event
- April 5, 2022
- Report Date
- July 27, 2022
- 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: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED AS A DEFAULT. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2201075. MEDICAL DEVICE EXPIRATION DATE: 31 DEC 2026. DEVICE MANUFACTURE DATE: 12 JAN 2022. MEDICAL DEVICE LOT #: 2201023. MEDICAL DEVICE EXPIRATION DATE: 31 DEC 2026. DEVICE MANUFACTURE DATE: 27 DEC 2021. MEDICAL DEVICE LOT #: 2103072. MEDICAL DEVICE EXPIRATION DATE: 28 FEB 2026. DEVICE MANUFACTURE DATE: 15 MAR 2021. . MEDICAL DEVICE LOT #: 2106098. MEDICAL DEVICE EXPIRATION DATE: 31 MAY 2026. DEVICE MANUFACTURE DATE: 17 JUN 2021. MEDICAL DEVICE LOT #: 2107108. . MEDICAL DEVICE EXPIRATION DATE: 30 JUN 2026. DEVICE MANUFACTURE DATE: 19 JULY 2021. 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 NO PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR EVALUATION. TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, NO SIGN OF FLUID OR EXCESS SILICONE CAN BE OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOTS 2201075, 2201023, 2103072, 2106098, AND 2107108, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF EACH LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCTS WERE VISUALLY INSPECTED, NO FOREIGN MATTER OR OTHER LIQUID WAS OBSERVED INSIDE ANY OF THE SYRINGES. IT IS POSSIBLE THE LIQUID THAT WAS WAS DESCRIBED TO BE OBSERVED IN THE SYRINGE WAS SILICONE. LUBRICANT IS EMPLOYED DURING THE SYRINGE ASSEMBLY PROCESS TO LUBRICATE THE CYLINDERS IN THE SILICONE STATION. THE SILICONE EMPLOYED IN THIS PRODUCT IS A MEDICAL GRADE SILICONE AUTHORIZED FOR PRODUCT USE. SILICONE CONTENT TESTS ARE PERFORMED DURING THE MANUFACTURING PROCESS OF EACH LOT NUMBER. RESULTS WERE REVIEWED FOR LOTS 2201075, 2201023, 2103072, 2106098, AND 2107108 AND FOUND TO BE WITHIN SPECIFICATION. SILICONE CAN BE VISIBLE DUE TO ISSUES RELATED TO POOR DISTRIBUTION INSIDE THE BARREL. AS NO DEFECT WAS OBSERVED IN THE RETAINED SAMPLES AND DEVICE RECORDS DO NOT INDICATE ANY ISSUES OCCURRED DURING MANUFACTURING, A DEFINITIVE ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS CANNOT BE IDENTIFIED AT THIS TIME. H
IT WAS REPORTED THAT BD PLASTIPAK¿ - 3-PIECE SYRINGES CONTAINED FOREIGN MATTER IN THE DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT IS A SHINY SUBSTANCE PARTIALLY PRESENT ON THE SURFACE AND/OR EDGES OF THE BLACK RUBBER OF THE PISTON, REMINISCENT OF A LUBRICANT; THIS SUBSTANCE CAN BE REMOVED WITH A COMPRESS. "
IT WAS REPORTED THAT BD PLASTIPAK¿ - 3-PIECE SYRINGES CONTAINED FOREIGN MATTER IN THE DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT IS A SHINY SUBSTANCE PARTIALLY PRESENT ON THE SURFACE AND/OR EDGES OF THE BLACK RUBBER OF THE PISTON, REMINISCENT OF A LUBRICANT; THIS SUBSTANCE CAN BE REMOVED WITH A COMPRESS. "
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1529197 | BD PLASTIPAK¿ - 3-PIECE SYRINGE | PISTON SYRINGE | FMF | BECTON DICKINSON, S.A. | SEE H.10. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |