BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ 20ML SYRINGE LUER SLIP

    MDR report key: 10477727 · Received September 1, 2020

    Report

    Report Number
    3003916417-2020-00254
    Event Type
    Malfunction
    Date Received
    September 1, 2020
    Date of Event
    August 10, 2020
    Report Date
    September 8, 2020
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: IT WAS PERFORMED THE DHR, MAINTENANCE RECORD ANALYSIS AND QUALITY NOTIFICATION ANALYSIS AND NO DEVIATIONS WERE FOUND FOR THIS BATCH. PHOTOS WERE SENT BY THE CUSTOMER AND IT WAS POSSIBLE TO OBSERVE TOP WEB PACKAGE MIX, SYRINGE LL X LS. ACCORDING THE EVALUATION OF BATCH HISTORY AND PROCESS THE POTENTIAL CAUSES FOR THE OCCURRENCE ARE: 1 - OPERATIONAL FAILURE DURING LINE SETUP AND LINE CLEARANCE, LEADING TO THE TOP WEB MIX. 2 - FAILURE AT LOGISTIC STEP OF MATERIAL SEPARATION, LEADING TO THE TOP WEB MIX. AS ACTIONS FOR THE INCIDENT: 1 - THE OPERATORS OF THE LINE INVOLVED, AND THE LOGISTICS TEAM WILL BE NOTIFIED OF THE OCCURRENCE. 2 - THE MAINTENANCE ORDER WAS OPENED TO REPLACE THE PAPER CONTROL SENSORS OF THE PACKAGING - SAP # 20560868 3 - THE SITUATION ANALYSIS # MDS-20-3917 WAS OPENED TO ADDRESS ANY ADDITIONAL ACTION NEEDED. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1,448 BD PLASTIPAK¿ 20ML SYRINGE LUER SLIPS EXPERIENCED A MIX OF PRODUCT TYPES IN A PACK AND INCORRECT LABEL INFORMATION. PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DIVERGENCE BETWEEN THE PRODUCT INFORMED IN THE PACKAGE AND THE ONE THAT IT'S ACTUALLY PACKED. THE 20ML SYRINGE LUER LOCK IN THE IDENTIFICATION IS CORRECT, BUT THE MATERIAL INSIDE OF IT IT'S THE LUER SLIP SYRINGE. IT WAS SEPARATED 1448 UNITS IN THE CUSTOMER'S STOREHOUSE OF BATCH 9326888 (MATERIAL # 990173). PACKAGE OF MATERIAL: 990687; MATERIAL THAT HAS ACTUALLY COME INSIDE THE PACKAGE: 990173, BATCH 9326888 IT'S NOT POSSIBLE TO IDENTIFY THE BATCH FOR PRODUCT 990687; THE LABEL IN THE BOX IS FOR PRODUCT MATERIAL # 990173 AND BATCH # 9326888; THE BATCH PRINTED IN THE BLISTERS IS # 9326888 (MATERIAL # 990173); THE PRODUCT INSIDE THE BLISTER IS MATERIAL # 990173; THE PAPER IN THE BACK OF THE BLISTER IS FOR PRODUCT # 990687 (UNKNOWN BATCH)

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 1,448 BD PLASTIPAK¿ 20ML SYRINGE LUER SLIPS EXPERIENCED A MIX OF PRODUCT TYPES IN A PACK AND INCORRECT LABEL INFORMATION. PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DIVERGENCE BETWEEN THE PRODUCT INFORMED IN THE PACKAGE AND THE ONE THAT IT'S ACTUALLY PACKED. THE 20ML SYRINGE LUER LOCK IN THE IDENTIFICATION IS CORRECT, BUT THE MATERIAL INSIDE OF IT IT'S THE LUER SLIP SYRINGE. IT WAS SEPARATED 1448 UNITS IN THE CUSTOMER'S STOREHOUSE OF BATCH 9326888 (MATERIAL # 990173). PACKAGE OF MATERIAL: 990687; MATERIAL THAT HAS ACTUALLY COME INSIDE THE PACKAGE: 990173, BATCH 9326888. IT'S NOT POSSIBLE TO IDENTIFY THE BATCH FOR PRODUCT 990687; THE LABEL IN THE BOX IS FOR PRODUCT MATERIAL # 990173 AND BATCH # 9326888; THE BATCH PRINTED IN THE BLISTERS IS # 9326888 (MATERIAL # 990173); THE PRODUCT INSIDE THE BLISTER IS MATERIAL # 990173; THE PAPER IN THE BACK OF THE BLISTER IS FOR PRODUCT # 990687 (UNKNOWN BATCH).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945018 BD PLASTIPAK¿ 20ML SYRINGE LUER SLIP LUER SLIP TIP FMF BECTON DICKINSON IND. CIRURGICAS LTDA 9326888

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other