BD LUER-LOK
Report
- Report Number
- 1213809-2023-01532
- Event Type
- Malfunction
- Date Received
- January 11, 2024
- Date of Event
- December 19, 2023
- Report Date
- January 26, 2024
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 30382903096054
- PMA / PMN Number
- K110771
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
PR 9445736 - FOLLOW UP MDR FOR DEVICE EVALUATION. IT WAS REPORTED ONE SYRINGE WAS FOUND DEFECTIVE AND ONE TRAY WAS UNDERFILLED BY TWO SYRINGES. TO AID IN THE INVESTIGATION, ONE SAMPLE OF A 10ML LUER LOK SYRINGE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE LOOSE SAMPLE HAS DAMAGE TO THE BARREL AND A 1" CRACK IN THE PLUNGER ROD. THESE CONDITIONS OBSERVED ARE NON-CONFORMING PER PRODUCT SPECIFICATION AND ASSOCIATED WITH THE ASSEMBLY PROCESS. NO SAMPLES WERE RECEIVED FOR SHORT COUNT BUT WILL BE ACKNOWLEDGED BASED ON THE DESCRIPTION. THE SHORT COUNT DEFECT IS ASSOCIATED WITH THE PACKAGING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309605, LOT 3152757. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. LOT 3152757 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN, SUBSEQUENTLY APPROVED FOR SHIPMENT AND IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. THESE DEFECTS ARE OCCURRING AT OR BELOW THEIR EXPECTED FREQUENCY; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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.
IT WAS REPORTED THAT THE BD LUER-LOK SYRINGE PLUNGER ROD WAS BROKEN/DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING COMPOUNDING (LOT #20231219-08D09D) ONE SYRINGE WAS FOUND DEFECTIVE AND 1 TRAY WAS FOUND TO BE UNDERFILLED BY 2 STERILE SYRINGES. THE DEFECTIVE UNIT IS AVAILABLE FOR RETURN. PLEASE LET ME KNOW THE OUTCOME OF THE INVESTIGATION." 12/19/2023 PCC-23-085 STERILE SYRINGE TRAY 10ML #309605 / EXPIRY 5-31-2028 3152757 CRACKED SYRINGE - 1 12/19/2023 PCC-23-085 STERILE SYRINGE TRAY 10ML #309605 / EXPIRY 5-31-2028 3152757 UNDERFILLED TRAY = 2 SYRINGES/1 TRAY PLEASE LET ME KNOW THE OUTCOME OF THE INVESTIGATION.
MATERIAL #: 309605, BATCH #: 3152757. IT WAS REPORTED BY CUSTOMER THAT ONE SYRINGE WAS FOUND DEFECTIVE AND 1 TRAY WAS FOUND TO BE UNDERFILLED BY 2 STERILE SYRINGES. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. DURING COMPOUNDING (LOT #20231219-08D09D) ONE SYRINGE WAS FOUND DEFECTIVE AND 1 TRAY WAS FOUND TO BE UNDERFILLED BY 2 STERILE SYRINGES. THE DEFECTIVE UNIT IS AVAILABLE FOR RETURN. . DID THE EVENT DIRECTLY, OR INDIRECTLY INVOLVE A PATIENT OR USER? NO. (B)(6) 2023 PCC-23-085 STERILE SYRINGE TRAY 10ML #309605 / EXPIRY 5-31-2028 3152757 CRACKED SYRINGE - 1. (B)(6) 2023 PCC-23-085 STERILE SYRINGE TRAY 10ML #309605 / EXPIRY 5-31-2028 3152757 UNDERFILLED TRAY = 2 SYRINGES/1 TRAY. PLEASE LET ME KNOW THE OUTCOME OF THE INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2057806 | BD LUER-LOK | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 3152757 | 30382903096054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |