BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 3ML VETERINARY SYRINGE WITH 22G X 1" NEEDLE

    MDR report key: 7678974 · Received July 11, 2018

    Report

    Report Number
    3003916417-2018-00143
    Event Type
    Malfunction
    Date Received
    July 11, 2018
    Date of Event
    June 18, 2018
    Report Date
    August 16, 2018
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLES/ PHOTOS ANALYSIS: A SAMPLE WAS RECEIVED FOR THE DEFECT REFERRING TO LOT 7069517 WHERE IT WAS POSSIBLE TO OBSERVE THE CRACKED CYLINDER DEFECT. NO SAMPLE OR PHOTO RECEIVED FOR 7143585. THERE IS NO EVIDENCE OF FAILURE FOR LOT 7143585, IT IS NOT POSSIBLE TO CONFIRM THE OCCURRENCE FOR THIS. DHR REVIEW: THE MANUFACTURING DATE FOR THE BATCH WAS: BATCH 7069517: APRIL, 06TH TO 08TH, 2017. BATCH 7143585: JUNE, 07TH TO 10TH, 2017. THE PROCESS INSPECTIONS WERE PERFORMED AT PROPERLY FREQUENCY AND NO RECORDS OF THIS DEFECT WERE FOUND. THE CURRENT CONTROLS AT MANUFACTURING PROCESS TO DETECT THE DEFECT ARE PERFORMED BY VISUAL INSPECTION WITH EACH 2 HOURS AT 36 PARTS AT ASSEMBLY MACHINE. NO RECORDS RELATED TO FAILURE WERE FOUND. HOWEVER, THE WAY IN WHICH THE SYRINGE PACKAGING WAS OPENED, WHICH WAS DONE IN AN INADEQUATE WAY, COULD CONTRIBUTE TO DAMAGE THE PRODUCT. THE INTERNAL ACTION FOR PRODUCT QUALITY IMPROVEMENT, WILL BE PERFORMED THE BLITZ # 44/2018 FOR DEFECTS OF DAMAGED COMPONENTS AND LEAKAGE. 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. BASED ON THE SEVERITY AND OCCURRENCE A CAPA IS NOT REQUIRED.

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURER: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BARREL OF A BD PLASTIPAK¿ 3ML VETERINARY SYRINGE WITH 22G X 1" NEEDLE HAD BARREL CRACKED, WHICH CAUSE LEAKAGE OF MEDICATION. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BARREL OF A BD PLASTIPAK 3ML VETERINARY SYRINGE WITH 22G X 1" NEEDLE HAD BARREL CRACKED, WHICH CAUSE LEAKAGE OF MEDICATION. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7069517, MEDICAL DEVICE EXPIRATION DATE: 03/31/2022, DEVICE MANUFACTURE DATE: 04/05/2017. MEDICAL DEVICE LOT #: 7143585, MEDICAL DEVICE EXPIRATION DATE: 05/31/2022, DEVICE MANUFACTURE DATE: 05/31/2017. 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 THE BARREL OF A BD PLASTIPAK¿ 3 ML VETERINARY SYRINGE WITH 22G X 1" NEEDLE HAD BARREL CRACKED, WHICH CAUSE LEAKAGE OF MEDICATION. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522231 BD PLASTIPAK¿ 3ML VETERINARY SYRINGE WITH 22G X 1" NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON IND. CIRURGICAS LTDA SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other