BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK LUER-LOK TIP

    MDR report key: 10237771 · Received July 6, 2020

    Report

    Report Number
    1213809-2020-00439
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Date of Event
    June 15, 2020
    Report Date
    July 24, 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, US
    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: 6/29/2020. H.6. INVESTIGATION: THREE LOOSE 3ML SYRINGES WITH NEEDLES ATTACHED AND TWO OPENED BLISTER PACKS FROM BATCH 0072336 (P/N 309657) WERE RECEIVED AND EVALUATED. ALL THE SYRINGES WERE MANIPULATED AND CONTAINED SMALL AMOUNTS OF CLEAR FLUID INSIDE. IT WAS OBSERVED IN EACH OF THE SYRINGES THERE WAS A SMALL WHITE CYLINDRICAL FOREIGN MATTER PARTICLE INSIDE THE FLUID PATH. THE PARTICLE APPEARED TO BE A SMALL PIECE OF RUBBER. DHR WAS PERFORMED. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 0072336 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. THE FOREIGN MATTER COULD NOT BE CONFIRMED TO HAVE ORIGINATED FROM THE MANUFACTURING SITE. IT IS POSSIBLE THE FOREIGN MATTER IS A PORTION OF THE VIAL SEPTUM. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF 3 ML BD LUER-LOK¿ LUER-LOK¿ TIPS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657 BATCH NO: 0072336. ¿ CALLER REPORTED SEEING A PIECE OF FLOATING BLACK PLASTIC IN SYRINGE, ABOUT .5 CM LONG ON 3-5 OCCASIONS OVER THE PAST 1-2 MONTHS. CUSTOMER UNSURE OF EXACT EVENT DATES. CUSTOMER STATED IT DID NOT PREVENT HIM FROM BEING ABLE DRAW INSULIN OUT OF VIAL OR TO FILL CARTRIDGE. ¿ NUMBER OF OCCURRENCES - 3-5. ¿ DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? - NO ¿ PRODUCT WITH ISSUE - BD 3ML SYRINGE, PN 309657. ¿ PRODUCT LOT # - 0072336 FOR AT LEAST THE MOST RECENT INCIDENT, CUSTOMER UNSURE OF PREVIOUS LOT NUMBERS OR IF ANY WERE FROM SAME LOT. ¿ DID ISSUE CAUSE ANY INJURY? - NO. ¿ DID CUSTOMER REQUIRE MEDICAL INTERVENTION? - NO.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 AN UNSPECIFIED NUMBER OF 3 ML BD LUER-LOK¿ LUER-LOK¿ TIPS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657 BATCH NO: 0072336. CALLER REPORTED SEEING A PIECE OF FLOATING BLACK PLASTIC IN SYRINGE, ABOUT .5 CM LONG ON 3-5 OCCASIONS OVER THE PAST 1-2 MONTHS. CUSTOMER UNSURE OF EXACT EVENT DATES. CUSTOMER STATED IT DID NOT PREVENT HIM FROM BEING ABLE DRAW INSULIN OUT OF VIAL OR TO FILL CARTRIDGE. NUMBER OF OCCURRENCES - 3-5. DID THE CALLER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? - NO. PRODUCT WITH ISSUE - BD 3ML SYRINGE, PN 309657. PRODUCT LOT # - 0072336 FOR AT LEAST THE MOST RECENT INCIDENT, CUSTOMER UNSURE OF PREVIOUS LOT NUMBERS OR IF ANY WERE FROM SAME LOT. DID ISSUE CAUSE ANY INJURY? - NO. DID CUSTOMER REQUIRE MEDICAL INTERVENTION? - NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695578 3 ML BD LUER-LOK LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 0072336 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other