BD LUER-LOK¿ SYRINGE
Report
- Report Number
- 1213809-2022-00054
- Event Type
- Malfunction
- Date Received
- February 8, 2022
- Date of Event
- January 20, 2022
- Report Date
- February 23, 2022
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- PMA / PMN Number
- K941562
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
CORRECTION: THE CUSTOMER PROVIDED THE CORRECT MATERIAL AND LOT#. THE FOLLOWING FIELDS HAVE BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE HAD NO SCALE MARKINGS ON IT. D.1. MEDICAL DEVICE BRAND NAME: BD LUER-LOK¿ SYRINGE. D.2. MEDICAL DEVICE CATALOG#: 309648. D.4. MEDICAL DEVICE LOT #: 1127509. D.4. MEDICAL DEVICE EXPIRATION DATE: 2026-04-30. D.5. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.5. PMA / 510(K)#: K941562. H.4. DEVICE MANUFACTURE DATE: 2021-05-07.
H.6. INVESTIGATION: ONE PHOTO WAS RECEIVED AND EVALUATED. THE PHOTO DISPLAYED A SINGLE 1ML LUER LOCK SYRINGE (P/N 309648) WITH A PIECE OF TAPE APPLIED TO THE COLLAR. THE GRADUATED SCALE WAS COMPLETELY MISSING FROM THE SYRINGE WHICH WAS A NON-CONFORMING CONDITION PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. 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.
IT WAS REPORTED THAT THE BD¿ LUER SLIP TIP SYRINGE HAD NO SCALE MARKINGS ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE WAS NO MARKINGS OF MEASUREMENT IN ONE OF THE SYRINGE IN THE PACK."
IT WAS REPORTED THAT THE BD¿ LUER SLIP TIP SYRINGE HAD NO SCALE MARKINGS ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE WAS NO MARKINGS OF MEASUREMENT IN ONE OF THE SYRINGE IN THE PACK."
IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE HAD NO SCALE MARKINGS ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE WAS NO MARKINGS OF MEASUREMENT IN ONE OF THE SYRINGE IN THE PACK."
IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE HAD NO SCALE MARKINGS ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE WAS NO MARKINGS OF MEASUREMENT IN ONE OF THE SYRINGE IN THE PACK."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1596004 | BD LUER-LOK¿ SYRINGE | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 1127509 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |