BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE BD ULTRAFINE 32GX4MM /10EA

    MDR report key: 11574334 · Received March 26, 2021

    Report

    Report Number
    9614033-2021-00032
    Event Type
    Malfunction
    Date Received
    March 26, 2021
    Date of Event
    March 2, 2021
    Report Date
    April 28, 2021
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT#: 4100307, D.4. MEDICAL DEVICE EXPIRATION DATE: 2019-03-31, H.4. DEVICE MANUFACTURE DATE: 2015-01-16, D.4. MEDICAL DEVICE LOT#: 5006500, D.4. MEDICAL DEVICE EXPIRATION DATE: 2019-12-31, H.4. DEVICE MANUFACTURE DATE: 2015-04-09 D.4. MEDICAL DEVICE LOT#: 2340015, D.4. MEDICAL DEVICE EXPIRATION DATE: 2017-11-30, H.4. DEVICE MANUFACTURE DATE: 2013-08-01, D.4. MEDICAL DEVICE LOT#: 3190471, D.4. MEDICAL DEVICE EXPIRATION DATE: 2018-06-30, H.4. DEVICE MANUFACTURE DATE: 2014-04-15. INVESTIGATION SUMMARY: CUSTOMER RETURNED A PHOTO OF A 4MM, 32G PEN NEEDLE FROM LOT#: 3190471. CUSTOMER STATES THAT THEY ARE CHECKING FOR THE EXPIRATION DATE. THE RETURNED PHOTO WAS EXAMINED AND NO EXPIRATION DATE WAS PRINTED ON THE SHOWN TEAR DROP LABEL. THIS PRODUCT WAS MANUFACTURED IN 2014 AND THE EXPIRATION DATE WAS PRINTED ON THE TEAR DROP LABEL DURING THIS TIME. AS PER MANUFACTURING, IT DOES NOT CARRY OUT A DOCUMENTARY REVIEW BECAUSE THE BATCHES REPORTED BY THE CUSTOMER EXPIRED IN 2018, AND THE BATCH RECORD IS ONLY SHELTERED DURING HIS EXPIRATION PERIOD. INVESTIGATION CONCLUSION: BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. RATIONALE: BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN NEEDLE BD ULTRAFINE 32GX4MM /10EA WAS MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320178, BATCH NO: 5006500, 4100307. IT WAS REPORTED THAT THE CUSTOMER IS CHECKING FOR THE EXPIRATION DATE.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 4100307. MEDICAL DEVICE EXPIRATION DATE: 2019-03-31. DEVICE MANUFACTURE DATE: 2015-01-16. MEDICAL DEVICE LOT #: 5006500. MEDICAL DEVICE EXPIRATION DATE: 2019-12-31. DEVICE MANUFACTURE DATE: 2015-04-09. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PEN NEEDLE BD ULTRAFINE 32GX4MM /10EA WAS MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320178 BATCH NO: 5006500, 4100307 IT WAS REPORTED THAT THE CUSTOMER IS CHECKING FOR THE EXPIRATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471141 PEN NEEDLE BD ULTRAFINE 32GX4MM /10EA PEN NEEDLE FMI BECTON DICKINSON DE MEXICO SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1