BD LUER-LOK¿ SYRINGE STERILE
Report
- Report Number
- 1213809-2022-00063
- Event Type
- Malfunction
- Date Received
- February 10, 2022
- Date of Event
- January 28, 2022
- Report Date
- March 4, 2022
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 30382903096467
- PMA / PMN Number
- K980987
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- 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.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D4: MEDICAL DEVICE LOT #: 1217815. D4: MEDICAL DEVICE EXPIRATION DATE: 2026-07-31. H4: DEVICE MANUFACTURE DATE: 2021-08-05. D4: MEDICAL DEVICE LOT #: 1231222. D4: MEDICAL DEVICE EXPIRATION DATE: 2026-07-31. H4: DEVICE MANUFACTURE DATE: 2021-08-19. D10: DEVICE AVAILABLE FOR EVALUATION: YES. D10: RETURNED TO MANUFACTURER ON: 2022-02-22. H6: INVESTIGATION SUMMARY: TWO PHOTOS, FOUR OPENED EMPTY PACKAGES, AND SEVEN 5ML SYRINGES, ONE OF WHICH WAS IN A SEALED PACKAGE FROM BATCH #1287477 (P/N 309646) WERE RECEIVED AND EVALUATED. THE EMPTY PACKAGES WERE FROM BATCHES 1217815, 1287477, AND 1231222. THREE OF THE LOOSE SAMPLES WERE OBSERVED TO HAVE A CUSTOMER ATTACHED TIP CAP. ALL OF THE SYRINGE SAMPLES WERE OBSERVED TO HAVE AN OILY FILM AT THE STOPPER, THIS MATERIAL IS MOST LIKELY SILICONE LUBRICANT FROM THE ASSEMBLY PROCESS. SIX OF THE SEVEN SAMPLES HAD THE NORMAL EXPECTED AMOUNT OF SILICONE PRESENT WHILE ONE SAMPLE WAS FOUND TO HAVE AN EXCESSIVE AMOUNT WHICH WAS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE EXCESSIVE SILICONE DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCHES #1287477, #1217815, AND #1231222 ARE CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.
IT WAS REPORTED BD LUER-LOK¿ SYRINGE STERILE HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SEVERAL SYRINGES HAVE HAD A OILY FILM AT THE STOPPER".
IT WAS REPORTED BD LUER-LOK¿ SYRINGE STERILE HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SEVERAL SYRINGES HAVE HAD A OILY FILM AT THE STOPPER".
IT WAS REPORTED BD LUER-LOK¿ SYRINGE STERILE HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SEVERAL SYRINGES HAVE HAD A OILY FILM AT THE STOPPER".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1799382 | BD LUER-LOK¿ SYRINGE STERILE | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 309646 | 1287477 | 30382903096467 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |