BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31G 6MM 10BAG 30BOX MEX

    MDR report key: 10451377 · Received August 25, 2020

    Report

    Report Number
    9614033-2020-00116
    Event Type
    Malfunction
    Date Received
    August 25, 2020
    Date of Event
    August 3, 2020
    Report Date
    August 26, 2020
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED A PHOTO OF A SYRINGE WITH THE POLY BAG FROM LOT#: 9252451. CUSTOMER STATES THAT THE NEEDLE SEPARATED FROM THE TUBE AND THERE ARE BROKEN PLUNGER ROD TABS. THE ATTACHED PHOTO WAS EXAMINED AND EXHIBITED A BROKEN BARREL TIP. NO BROKEN FLANGE WAS OBSERVED. DURING THE DOCUMENTARY REVIEW, NO RECORDS OF QUALITY EVENTS WERE FOUND THAT COULD CAUSE THE REPORTED DEFECT, THE LOT WAS INSPECTED AND SUBSEQUENTLY RELEASED ACCORDING TO THE IN FORCE WORK INSTRUCTION. CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BROKEN BARREL TIP). UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BROKEN FLANGE). PROCESS SUMMARY: AUTOMATIC SYRINGE ASSEMBLY MACHINE, WHICH FEEDS 0.5ML, SYRINGE COMPONENTS (BARREL, STOPPER, PLUNGER, NEEDLE ASSEMBLY & CAP) AND ASSEMBLES THESE COMPONENTS. THIS MACHINE CONSISTS OF A BARREL CLEANING DIAL, LUBRICATION DIAL, PLUNGER / STOPPER ASSEMBLY DIAL, SYRINGE ASSEMBLY DIAL, AND VARIOUS INSPECTIONS AND TRANSFER DIALS. BROKEN BARREL TIP: THERE WERE NO QUALITY NOTIFICATIONS OR MAINTENANCE DISPATCHES DURING THE PRODUCTION OF THIS BATCH THAT PERTAINED TO THIS DEFECT. A ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE THE SYRINGE 0.5ML 31G 6MM 10 BAG 30 BOX MEX HAD THE HUB SEPARATE FROM THE DEVICE AND THE PRODUCT WAS DAMAGED (BROKEN, MISSING, UNASSEMBLED). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED THE ¿NEEDLE SEPARATED FROM THE TUBE AND THERE ARE BROKEN PLUNGER TABS. ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER: THE SYRINGE'S BARREL HAS IN ITS UPPER PART SOME TABS THAT WORK AS A HOLDER, THEY ARE BROKEN. THERE WAS NO DIFFICULTY WITH THE ORANGE PROTECTOR (IT WAS NOT TIGHTER THAN USUAL), THE NEEDLE HAS COME ALREADY SEPARATED FROM THE SYRINGE.¿

    Additional Manufacturer Narrative · 1

    (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 DURING USE THE SYRINGE 0.5ML 31G 6MM 10BAG 30BOX MEX HAD THE HUB SEPARATE FROM THE DEVICE AND THE PRODUCT WAS DAMAGED (BROKEN, MISSING, UNASSEMBLED). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED THE ¿NEEDLE SEPARATED FROM THE TUBE AND THERE ARE BROKEN PLUNGER TABS. ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER: THE SYRINGE'S BARREL HAS IN ITS UPPER PART SOME TABS THAT WORK AS A HOLDER, THEY ARE BROKEN. THERE WAS NO DIFFICULTY WITH THE ORANGE PROTECTOR (IT WAS NOT TIGHTER THAN USUAL), THE NEEDLE HAS COME ALREADY SEPARATED FROM THE SYRINGE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916616 SYRINGE 0.5ML 31G 6MM 10BAG 30BOX MEX PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 9252451

    Patients

    Seq Age Sex Outcome Treatment
    1 Other