BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL 200 S/C

    MDR report key: 10892564 · Received November 24, 2020

    Report

    Report Number
    1213809-2020-00831
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    October 28, 2020
    Report Date
    November 30, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY TWO HUNDRED 3ML SYRINGES WERE RECEIVED AND EVALUATED. 198 WERE IN FULLY SEALED BLISTER PACKS FROM BATCH 0232783 (P/N 309657). TWO WERE LOOSE WITH OPENED PACKAGES AND ONE HAD AN UNKNOWN NEEDLE ATTACHED. IT APPEARED THE " CLEAR LIQUID SUBSTANCE" WAS SILICONE AND EACH OF THE SYRINGES CONTAINED THE NORMAL AND EXPECTED AMOUNT PER PRODUCT 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. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED. FURTHERMORE, 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 3ML LL 200 S/C HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657 BATCH NO:0232783 IT WAS REPORTED THAT THERE IS A CLEAR LIQUID SUBSTANCE AT THE PLUNGER CAUSING IT TO STICK, ONCE PULLED BACK HARD, IT GLIDES AS IT SHOULD. ODORLESS, COLORLESS, OILY/STICKY, WHEN I TOUCH THE PLUNGER, ITS TACKY AND MY FINGERPRINT IMPRESSION IS LEFT IN THE SUBSTANCE. VERBATIM: ONE OF THE HFHS MEDICAL GROUP LOCATIONS HAS OBSERVED AN ADDITIONAL PRODUCT ISSUE WITH THE BD 3 ML SYRINGE. ONLY ONE REPORTED SO FAR OBSERVED FROM THIS LOT. I TRIED CALLING BD YESTERDAY TO SEE IF THEY CAN SPEED UP THE EVALUATION OF THE SYRINGES ALREADY RETURNED. CAN YOU DO ANYTHING TO HELP WITH THIS? I AM TRYING TO AVOID HAVING TO SEQUESTER ANOTHER LARGE AMOUNT OF PRODUCT AT HFHS. THERE ARE NO RECALLS OR ALERTS RELATED TO THIS SO WE REALLY NEED TO KNOW WHAT THIS IS AND WHETHER THESE SYRINGES ARE SAFE FOR CONTINUED USE.

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 29 OCTOBER, 2020. MEDWATCH REPORT # (B)(4). REPORT SOURCE OTHER: MEDWATCH REPORT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 3ML LL 200 S/C HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657 BATCH NO:0232783. IT WAS REPORTED THAT THERE IS A CLEAR LIQUID SUBSTANCE AT THE PLUNGER CAUSING IT TO STICK, ONCE PULLED BACK HARD, IT GLIDES AS IT SHOULD. ODORLESS, COLORLESS, OILY/STICKY, WHEN I TOUCH THE PLUNGER, ITS TACKY AND MY FINGERPRINT IMPRESSION IS LEFT IN THE SUBSTANCE. VERBATIM: ONE OF THE HFHS MEDICAL GROUP LOCATIONS HAS OBSERVED AN ADDITIONAL PRODUCT ISSUE WITH THE BD 3 ML SYRINGE. ONLY ONE REPORTED SO FAR OBSERVED FROM THIS LOT. I TRIED CALLING BD YESTERDAY TO SEE IF THEY CAN SPEED UP THE EVALUATION OF THE SYRINGES ALREADY RETURNED. CAN YOU DO ANYTHING TO HELP WITH THIS? I AM TRYING TO AVOID HAVING TO SEQUESTER ANOTHER LARGE AMOUNT OF PRODUCT AT HFHS. THERE ARE NO RECALLS OR ALERTS RELATED TO THIS SO WE REALLY NEED TO KNOW WHAT THIS IS AND WHETHER THESE SYRINGES ARE SAFE FOR CONTINUED USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354782 SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 0232783 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1