BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY

    MDR report key: 11580025 · Received March 27, 2021

    Report

    Report Number
    2243072-2021-00890
    Event Type
    Malfunction
    Date Received
    March 27, 2021
    Date of Event
    March 3, 2021
    Report Date
    April 15, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-03-18. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (79) OPEN 4MM, 32G PEN NEEDLES WITHOUT THE TEAR DROP LABEL. CUSTOMER STATES THAT THE PEN NEEDLE CLOGS DURING FLOW CHECK. ALL RETURNED PEN NEEDLES WERE EXAMINED AND 73 OUT OF 79 RETURNED PEN NEEDLES EXHIBITED A BENT NON PATIENT END OF THE CANNULA, WHICH COULD PREVENT INSULIN FROM PROPERLY FLOWING THROUGH THE CANNULA. ALL REMAINING SAMPLES WERE TESTED AND ALL WERE ABLE TO EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. UNABLE TO PERFORM DHR CHECK FOR CLOG DUE TO UNKNOWN LOT NUMBER. ROOT CAUSE IS USER RELATED. THE NON PATIENT END OF THE CANNULA WAS BENT DURING USE OF THE PRODUCT BY THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY WAS UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT DURING FLOW CHECK PEN NEEDLE CLOGS. VERBATIM: CONSUMER REPORTED FINDING DURING THE FLOW CHECK IT CLOGS. SHE DOES NOT REVIEW THE NON PATIENT END IF ITS BENT. CANT SEE IT. CONSUMER HAS SEVERAL PRIOR FILES CS0025092 & CS0006660 LOT # 9259246 & UNKNOWN LOT #, CATALOG# 320883, DATE OF EVENT UNKNOWN. ALL WITHIN PAST YEAR, SAMPLE STATUS AWAITING SAMPLES."

    Additional Manufacturer Narrative · 1

    "UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED IN AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY WAS UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT DURING FLOW CHECK PEN NEEDLE CLOGS. VERBATIM: CONSUMER REPORTED FINDING DURING THE FLOW CHECK IT CLOGS. SHE DOES NOT REVIEW THE NON PATIENT END IF ITS BENT. CANT SEE IT. CONSUMER HAS SEVERAL PRIOR FILES (B)(6) LOT # 9259246 & UNKNOWN LOT #. CATALOG# 320883. DATE OF EVENT UNKNOWN. ALL WITHIN PAST YEAR. SAMPLE STATUS AWAITING SAMPLES"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476972 PEN NDL 32G 4MM 90 CT MAIL ORDER ONLY HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1