BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK TIP SYRINGE

    MDR report key: 10399813 · Received August 12, 2020

    Report

    Report Number
    1213809-2020-00527
    Event Type
    Malfunction
    Date Received
    August 12, 2020
    Date of Event
    July 21, 2020
    Report Date
    September 14, 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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 8/17/2020. H.6. INVESTIGATION: THREE LOOSE SYRINGES WITH NEEDLES ATTACHED WERE RECEIVED, AS WELL ASS SEVERAL PIECES OF TOP WEB AND LOOSE PIECES OF GAUZE, ALL IN A PLASTIC ZIP LOCK BAG. THE SAMPLES WERE VISUALLY EVALUATED THROUGH THE BAG DUE TO CLEAR SIGNS OF MANIPULATION AND POTENTIAL USE. ONE SYRINGE HAD A SHIELDED SAFETYGLIDE NEEDLE ATTACHED AND LESS THAN 1ML OF CLEAR LIQUID IN THE FLUID PATH. IT WAS OBSERVED TO HAVE A PIECE OF GRAY FOREIGN MATTER ON THE STOPPER SURFACE LARGER THAN LEVEL 3 IN SIZE. THE FM APPEARED TO BE A LONG SHAVED OFF PIECE OF A VIAL STOPPER OR SIMILAR ¿ THE DEFECT LIKELY NOT ASSOCIATED WITH SYRINGE MANUFACTURING PROCESS. ONE SYRINGE HAD A SAFETYGLIDE NEEDLE ATTACHED WITH SAFETY ACTIVATED. IT WAS OBSERVED TO HAVE A SLIGHTLY INSECURE STOPPER. UPON CLOSER INSPECTION, IT WAS DETERMINED THAT THE STOPPER WAS NOT ATTACHED ON ONE SIDE OF THE PLUNGER TIP DUE TO DAMAGED PLUNGER ROD CROWN. ONE SYRINGE HAD A BLUNT FILL NEEDLE ATTACHED. THE PLUNGER WAS PULLED BACK AND FORTH ONCE WITH NO IMPEDANCE OBSERVED ¿ NO DEFECTS FOUND IN THIS SAMPLE. FIVE SEALED PACKAGED 3ML SYRINGES, CONFIRMED TO BE FROM BATCH #9302403 (P/N 309657), WERE ALSO RECEIVED LOOSE IN THE ENVELOPE. THE SAMPLES WERE TAKEN OUT OF THE PACKAGES AND VISUALLY EVALUATED. NO FOREIGN MATTER WAS FOUND IN THE SAMPLES. NO PLUNGER MOVEMENT DIFFICULTIES WERE FOUND IN THE SAMPLES. NO DEFECTS WERE CONFIRMED IN ANY OF THE FIVE SAMPLES. THE PRODUCT IS SOLD AS SYRINGE-ONLY. THE NEEDLE DEVICES ATTACHED WERE ADDED BY END USER AND NOT PART OF THE SYRINGE DEVICE AS SOLD. POTENTIAL ROOT CAUSE FOR THE INSECURE STOPPER DEFECT IS A BROKEN PLUNGER ROD DUE TO MATERIAL HANDLING PROCESS. 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 1 BD LUER-LOK¿ TIP SYRINGE FROM LOT 9302403 HAD A "BLACK FLECK" IN THE SERUM THAT WAS NOTICED WHILE DRAWING IT UP; ADDITIONALLY, THE PLUNGER BROKE IN 1 SYRINGE FROM LOT 9081635 DURING AN IMMUNIZATION VACCINE FOR AN INFANT, AND 1 SYRINGE FROM LOT 9302403 HAD A "MORPHED PLUNGER". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECENTLY HAD 3 INSTANCES WITH BD 3ML SYRINGES. THE FIRST INSTANCE, OUR RN DREW UP THE SERUM AND NOTICED A BLACK FLECK IN THE SERUM. RN UNSURE IF FROM PLUNGER. WE HAD TO PAY FOR REPLACEMENT VACCINE. LOT# 9302403. THE SECOND INSTANCE, THE RN WAS GIVING A BABY THEIR IMMUNIZATION AND THE VACCINE WAS PUSHED UP ABOVE THE PLUNGER IN SYRINGE AND THE SERUM REMAINED IN THE SYRINGE WHEN ATTEMPTING TO ADMINISTER TO PATIENT. LOT# 9081635 THE THIRD INSTANCE IS A MORPHED PLUNGER. LOT# 9302403 SINCE THE FIRST AND THIRD INSTANCE HAS THE SAME LOT NUMBER, I PULLED THE REMAINING SYRINGES.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9302403, MEDICAL DEVICE EXPIRATION DATE: 2024-09-30, DEVICE MANUFACTURE DATE: 2019-10-29, MEDICAL DEVICE LOT #: 9081635, MEDICAL DEVICE EXPIRATION DATE: 2024-02-29, DEVICE MANUFACTURE DATE: 2019-03-22. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1 BD LUER-LOK¿ TIP SYRINGE FROM LOT 9302403 HAD A "BLACK FLECK" IN THE SERUM THAT WAS NOTICED WHILE DRAWING IT UP; ADDITIONALLY, THE PLUNGER BROKE IN 1 SYRINGE FROM LOT 9081635 DURING AN IMMUNIZATION VACCINE FOR AN INFANT, AND 1 SYRINGE FROM LOT 9302403 HAD A "MORPHED PLUNGER". THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECENTLY HAD 3 INSTANCES WITH BD 3 ML SYRINGES. THE FIRST INSTANCE, OUR RN DREW UP THE SERUM AND NOTICED A BLACK FLECK IN THE SERUM. RN UNSURE IF FROM PLUNGER. WE HAD TO PAY FOR REPLACEMENT VACCINE. LOT# 9302403. THE SECOND INSTANCE, THE RN WAS GIVING A BABY THEIR IMMUNIZATION AND THE VACCINE WAS PUSHED UP ABOVE THE PLUNGER IN SYRINGE AND THE SERUM REMAINED IN THE SYRINGE WHEN ATTEMPTING TO ADMINISTER TO PATIENT. LOT# 9081635 THE THIRD INSTANCE IS A MORPHED PLUNGER. LOT# 9302403 SINCE THE FIRST AND THIRD INSTANCE HAS THE SAME LOT NUMBER, I PULLED THE REMAINING SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864278 BD LUER-LOK TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 SEE SECTION H.10. 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other