BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 18093032 · Received November 8, 2023

    Report

    Report Number
    1213809-2023-01232
    Event Type
    Malfunction
    Date Received
    November 8, 2023
    Date of Event
    October 3, 2023
    Report Date
    February 22, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096955
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR 9070575 ¿ FOLLOW UP MDR FOR DEVICE EVALUATION IT WAS REPORTED THE FLANGES WERE BREAKING OFF SYRINGES. TO AID IN THE INVESTIGATION, ONE SAMPLE OF A 10ML CONTROL SYRINGE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLE WAS LOOSE WITH THE FINGER GRIP BROKEN AND A SMALL PORTION STILL CONNECTED TO THE BARREL FLANGE AT THE WELD. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION AND ASSOCIATED WITH THE WELDER ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309695, LOT 2343589. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH ONE QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. A REQUALIFICATION WAS PERFORMED, AND THE LINE CLEARED OF DEFECTS. HOWEVER, IT IS POSSIBLE A LIMITED NUMBER OF PIECES WITH THIS CONDITION WERE ABLE TO ESCAPE DETECTION. LOT 2343589 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. THIS CONDITION IS OCCURRING AT OR BELOW ITS 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. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD LUER-LOK SYRINGE BARREL/FLANGE WAS DAMAGED, THE FLANGES BROKE OFF DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿LOT# 2343589 THE ENTIRE SHIPMENT WAS AFFECTED. THE FLANGES WERE BREAKING OFF DURING INJECTION ON AT LEAST 10 PATIENTS.¿ (B)(6) 2023. 1. WHAT WAS THE QUANTITY RECEIVED FROM THE COMPLAINT LOT? TWO CASES WITH A QUANTITY TOTAL OF 200 SYRINGES. 2. IF UNUSED SAMPLES STILL SEALED IN BLISTER PACKAGES FROM THE LOT ARE AVAILABLE, PLEASE RETURN THEM. THESE UNUSED SAMPLES CAN BE USED TO PERFORM FUNCTIONAL TESTING PER INTERNAL SPECIFICATION TO DETERMINE IF THE FINGER AND THUMB GRIPS WERE WELDED TO THE FLANGES ACCORDING TO STANDARD. ONE BOX WILL BE RETURNED. 4. IS THERE ANY ADVERSE EVENT ON PATIENT? POSSIBLE LUNG PERFORATION ON TWO SURGICAL PATIENTS. 5. IS THERE ANY MEDICAL INTERVENTION NEEDED DUE TO THE INCIDENT? BOTH PATIENTS WERE MONITORED BY OUR ANESTHESIA PROVIDER FOR INSPIRATION AND EXPIRATION OF THEIR CHEST. DURING OBSERVATION INTRA-OP AND POST-OP, THERE WAS NO INDICATION OF A PNEUMOTHORAX PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753833 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2343589 30382903096955

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown