BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 12921691 · Received December 2, 2021

    Report

    Report Number
    1213809-2021-00794
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    November 4, 2021
    Report Date
    December 30, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: FOUR PHOTOS AND ONE HUNDRED 1ML LUER LOCK SYRINGES SEALED IN BAGS OF TWENTY-FIVE WERE RECEIVED AND EVALUATED. THE SYRINGES WERE VISUALLY EVALUATED AND NINETY-NINE WERE FOUND TO HAVE EXCESSIVE SILICONE ON THE PLUNGER ROD AND BEHIND THE STOPPER OUTSIDE OF THE FLUID PATH, AND BETWEEN THE STOPPER RIBS. ONE SYRINGE WAS NOTED TO HAVE A JAMMED STOPPER BECAUSE OF LACK OF SILICONE IN THE BARREL. THE OBSERVED CONDITIONS WERE NON-CONFORMING PER PRODUCT SPECIFICATION. THIS IS A KNOWN ISSUE FOR PRODUCTION BATCH #1127514. OF THE COMPLAINTS RECEIVED FOR THIS BATCH KNOWN POTENTIALLY IMPACTED BOXES ARE 97-184. THE BOX NUMBERS THAT THE CUSTOMER CURRENTLY HAS IN STOCK ARE REQUIRED TO DETERMINE IF THE SCOPE EXPANDS BEYOND THOSE JUST LISTED. POTENTIAL ROOT CAUSE FOR THE JAMMED STOPPER AND LACK OF SILICONE DEFECT ARE ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCHES #0059908, #1083799, #1127514 ARE CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS FOR THESE DEFECTS. POTENTIAL ROOT CAUSES FOR THE EXCESSIVE SILICONE DEFECT WERE DETERMINED TO BE THE FOLLOWING: IMPROPER POSITIONING OF THE SILICONE GUN LEADING TO OVERSPRAY ON BARREL FLANGES AND THE MACHINE DIAL. EXCESSIVE SILICONE PRESENCE DUE TO THE MISUSE OF THE SILICONE GUN PURGE FUNCTION. INADEQUATE CAPTURE AND CONFLICTION IN INSPECTION PROCEDURES FOR SILICONE OUTSIDE OF THE FLUID PATH. IMPROPER ADJUSTMENT REQUIREMENTS FOR SILICONE PURGE FUNCTION. THE FOLLOWING CORRECTIVE ACTIONS HAVE BEEN AND WILL BE TAKEN IN RESPONSE TO THIS COMPLAINT AND OTHERS RECEIVED FOR THIS BATCH AROUND EXCESSIVE SILICONE. ADDITIONALLY, LOCAL EXCEPTIONS REPORTS WERE OPENED TO TRACK ACTIONS AROUND THIS COMPLAINT. THE SILICONE GUN WILL BE PINNED DOWN AT THE OPTIMAL LOCATION TO PREVENT SILICONE OVERSPRAY FROM OCCURRING. COMPLETED: 11/2021 THE SILICONE PURGE FUNCTION WILL NO LONGER BE ACCESSIBLE TO ANY OPERATORS ON THE MACHINE. ELECTRONIC CONTROLS WILL BE PUT IN PLACE TO ONLY ALLOW AUTHORIZED ENGINEERS AND TECHNICIANS ACCESS TO THE PURGE FUNCTION. DUE: 03/31/2022 THE PROGRAM WILL BE UPDATED TO NOT ALLOW THE MACHINE TO RUN WHILE THE SILICONE GUN IS PURGING. DUE: 03/31/2022 UPDATE INSPECTION PROCEDURES AND INTERNAL GUIDEBOOKS TO ADEQUATELY CAPTURE THIS DEFECT. DUE: 03/31/2022 ADJUSTMENT PROCEDURE FOR SILICONE GUN PURGE FUNCTION WILL BE UPDATED TO PROPERLY QUALIFY PRODUCT AND CLEAN IMPACTED MACHINE AREAS POST PURGE. DUE: 03/31/2022. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED BATCH NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE LOT #: POSSIBLE LOT #S PROVIDED: 0059908, 1083799, 1127514. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD LUER-LOK¿ SYRINGE THERE WAS FOREIGN MATTER IN THE DEVICE ON THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "IT HAS BEEN FOUND THERE IS A LOT OF SILICONE OIL IN THE SYRINGE. AFTER PULLING UP THE SYRINGE, THE OIL COLLECTS UNDER THE PLUNGER OF THE SYRINGE.".

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD LUER-LOK¿ SYRINGE THERE WAS FOREIGN MATTER IN THE DEVICE ON THE PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "IT HAS BEEN FOUND THERE IS A LOT OF SILICONE OIL IN THE SYRINGE. AFTER PULLING UP THE SYRINGE, THE OIL COLLECTS UNDER THE PLUNGER OF THE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1818640 BD LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown