BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 30GA 1/2IN

    MDR report key: 8819236 · Received July 23, 2019

    Report

    Report Number
    3002682307-2019-00412
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Date of Event
    July 9, 2019
    Report Date
    August 9, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 304000 LOTS 180312 AND 171108 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE. BD NEEDS TO TAKE INTO CONSIDERATION THAT THE MEDICATION COULD HAVE SOME POTENTIAL IMPLICATION IN THE ISSUE, ESPECIALLY IN SMALL GAUGES LIKE 30G. IN CERTAIN CIRCUMSTANCES THE DRUG PRODUCT CAN BE DEPOSITED INSIDE THE CANNULA CAUSING THE NEEDLE TO BLOCK/ OCCLUDE DUE TO CRYSTALLIZATION OR OTHER SOLUBLE EFFECTS. OCCLUSION IS MOST LIKELY TO OCCUR IF A DRUG REMAINS WITHIN THE NEEDLE FOR AN EXTENDED PERIOD OF TIME, AS CUSTOMER REPORTED, WHICH ALLOWS THE DRUG TO CRYSTALLIZE OR BE DEPOSITED ON THE INNER SURFACES OF THE NEEDLE. THE NEEDLES ARE 100% INSPECTED USING A CAMERA SYSTEM. THIS CAMERA SYSTEM SENSES A LIGHT SOURCE WHICH IS POSITIONED AT THE OPPOSITE END OF THE NEEDLE. IF THE CAMERA DOES NOT SENSE THE LIGHT SOURCE, AN OCCLUSION CONDITION MAY BE PRESENT AND AS A RESULT, THE NEEDLE IS AUTOMATICALLY REJECTED. IN ADDITION, THE NEEDLES ARE INSPECTED FOR THE OCCLUDED CANNULA CONDITION AS PART OF THE IN-PROCESS INSPECTION AFTER THE ASSEMBLING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO INJECTION IT WAS DISCOVERED THAT THE NEEDLE WAS CLOGGED AND MEDICATION DID NOT FLOW WITH A BD NEEDLE 30GA 1/2IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BEFORE INJECTION, THE PATIENT TESTED TO SEE IF THERE WAS MEDICINE COMING OUT, BUT THE NEEDLE WAS CLOGGED AND THE MEDICINE DIDN'T COME OUT.

    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 #: 171108; MEDICAL DEVICE EXPIRATION DATE: 2022-10-31 ; DEVICE MANUFACTURE DATE: 2017-11-08; MEDICAL DEVICE LOT #: 180312; MEDICAL DEVICE EXPIRATION DATE: 2023-02-28; DEVICE MANUFACTURE DATE: 2018-03-15. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO INJECTION IT WAS DISCOVERED THAT THE NEEDLE WAS CLOGGED AND MEDICATION DID NOT FLOW WITH A BD NEEDLE 30GA 1/2IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BEFORE INJECTION, THE PATIENT TESTED TO SEE IF THERE WAS MEDICINE COMING OUT, BUT THE NEEDLE WAS CLOGGED AND THE MEDICINE DIDN'T COME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609108 BD NEEDLE 30GA 1/2IN NEEDLE FMI BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other