BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL BNS

    MDR report key: 12550407 · Received September 29, 2021

    Report

    Report Number
    1213809-2021-00680
    Event Type
    Malfunction
    Date Received
    September 29, 2021
    Date of Event
    September 1, 2021
    Report Date
    October 1, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIRTY-SIX LOOSE 10ML LUER-LOCK SYRINGES WERE RECEIVED. THE SAMPLES WERE VISUALLY EVALUATED. TWELVE WERE IDENTIFIED AS COMING FROM BATCH #1152291 AND TWENTY-FOUR FROM BATCH #1168566. OF THE TWELVE SYRINGES FROM BATCH #1152291 EVALUATED SIX WERE OBSERVED TO HAVE EXCESSIVE SILICONE LUBRICANT IN THE FLUID PATH. SOME SILICONE SPRAY WAS OBSERVED ON THE FLANGES OF THE TWELVE SYRINGES BUT FELL WITHIN SPECIFICATION. OF THE TWENTY-FOUR SYRINGES FROM BATCH #1168566 EVALUATED FOURTEEN WERE OBSERVED TO HAVE EXCESSIVE SILICONE INSIDE THE FLUID PATH WHICH IS A NON-CONFORMING CONDITION PER PRODUCT SPECIFICATION. SOME SILICONE SPRAY WAS OBSERVED ON ALL FLANGES OF THE TWENTY-FOUR BUT FELL WITHIN SPECIFICATION. PLEASE NOTE THAT SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. THE SILICONE APPLICATION PROCESS IS DESIGNED TO PROVIDE AN EVEN DISTRIBUTION OF SILICONE ON THE INTERIOR OF THE SYRINGE BARREL. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. POTENTIAL ROOT CAUSE FOR THE EXCESS 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. THESE BATCHES 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 NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 10ML LL BNS HAD FOREIGN MATTER. THIS OCCURRED ON 11050 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED "OIL IN THE BLACK PLUNGER PORTION.".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1168566. MEDICAL DEVICE EXPIRATION DATE: 2026-06-30. DEVICE MANUFACTURE DATE: 2021-06-17. MEDICAL DEVICE LOT #: 1152291. MEDICAL DEVICE EXPIRATION DATE: 2026-05-31. DEVICE MANUFACTURE DATE: 2021-06-01. 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 · 1

    IT WAS REPORTED THAT SYRINGE 10ML LL BNS HAD FOREIGN MATTER. THIS OCCURRED ON 11050 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED "OIL IN THE BLACK PLUNGER PORTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445630 SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1