BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE

    MDR report key: 17438247 · Received August 1, 2023

    Report

    Report Number
    3003916417-2023-00192
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    July 13, 2023
    Report Date
    September 14, 2023
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E.1 INITIAL REPORTER PHONE #: (B)(6). MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2180551. D.4. MEDICAL DEVICE EXPIRATION DATE: 30-JUN-2027. H.4. DEVICE MANUFACTURE DATE: 29-JUN-2022. D.4. MEDICAL DEVICE LOT #: 2090637. D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2027. H.4. DEVICE MANUFACTURE DATE: 31-MAR-2022. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 17-AUG-2023. H6: INVESTIGATION SUMMARY: SAMPLE AND PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL EVALUATION, PACKAGED NEEDLES ARE OBSERVED, NO DEFECTS OR DAMAGES ARE OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2090637,2180551 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THIRTY-TWO RETAINED SAMPLES FROM THE SAME LOT WERE EVALUATED, NO HOLES OR OPEN SEAL OBSERVED. BASED ON OUR INVESTIGATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 OF THE BD PRECISIONGLIDE NEEDLE HAD STERILE BREACH OF UNIT PACKAGING. 1 OF 2 RELATED FILES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: 4 UNITS OF BATCH 2180551 WITH THE PACKAGING PERFORATED BY A BURR IN NEEDLE SHIELD; 1 UNIT OF BATCH 2090637 WITH THE PACKAGING PERFORATED BY A BURR IN NEEDLE SHIELD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 OF THE BD PRECISIONGLIDE NEEDLE HAD STERILE BREACH OF UNIT PACKAGING. 1 OF 2 RELATED FILES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: 4 UNITS OF BATCH 2180551 WITH THE PACKAGING PERFORATED BY A BURR IN NEEDLE SHIELD; 1 UNIT OF BATCH 2090637 WITH THE PACKAGING PERFORATED BY A BURR IN NEEDLE SHIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555377 BD PRECISIONGLIDE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown