BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK SYRINGE LUER SLIP

    MDR report key: 10237777 · Received July 6, 2020

    Report

    Report Number
    3003916417-2020-00192
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Date of Event
    June 15, 2020
    Report Date
    August 3, 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

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9326884 MAINTENANCE RECORD ANALYSIS AND QUALITY NOTIFICATION ANALYSIS AND NO DEVIATION 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 - ADDITIONALLY, THE INCIDENT REPORTED FROM THIS COMPLAINT WILL BE MONITORED FOR TREND EVALUATION. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BOX OF BD PLASTIPAK¿ SYRINGES WITH THE LUER SLIP CONTAINED LUER -LOK TIP SYRINGES INSTEAD, BUT THE BATCH LISTED ON THE LABEL FOR BOTH CATALOG NUMBERS WAS THE SAME. THIS WAS NOTICED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "PRODUCTS IDENTIFIED IN THE LUER PLASTIPAK SYRINGE BOX - SLIP 20 ML, REF 990173 LOT: 9326884 VAL 11-2024, BUT INSIDE CONTAINS THE LUER -LOK TIP SYRINGE REF990687. QUANTITY 750 UNITS. ADDITIONAL INFORMATION: IN TELEPHONE CONTACT THE CUSTOMER DESCRIBES THE LABEL THAT IDENTIFIES THE BOX AND IT IS UNDERSTOOD THAT IT APPEARS TO BE THE LABEL ISSUED BY THE FACTORY. IN ADDITION, SHE NOTES THAT THE BATCH OF BOTH CATALOGS IS THE SAME (9326884)."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE#: (B)(6). INITIAL REPORTER ADDRESS 1: (B)(6). 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 BOX OF BD PLASTIPAK¿ SYRINGES WITH THE LUER SLIP CONTAINED LUER -LOK TIP SYRINGES INSTEAD, BUT THE BATCH LISTED ON THE LABEL FOR BOTH CATALOG NUMBERS WAS THE SAME. THIS WAS NOTICED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: "PRODUCTS IDENTIFIED IN THE LUER PLASTIPAK SYRINGE BOX - SLIP 20 ML, REF 990173 LOT: 9326884 VAL 11-2024, BUT INSIDE CONTAINS THE LUER -LOK TIP SYRINGE REF990687. QUANTITY 750 UNITS. ADDITIONAL INFORMATION: IN TELEPHONE CONTACT THE CUSTOMER DESCRIBES THE LABEL THAT IDENTIFIES THE BOX AND IT IS UNDERSTOOD THAT IT APPEARS TO BE THE LABEL ISSUED BY THE FACTORY. IN ADDITION, SHE NOTES THAT THE BATCH OF BOTH CATALOGS IS THE SAME (9326884).".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696455 BD PLASTIPAK SYRINGE LUER SLIP PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 9326884

    Patients

    Seq Age Sex Outcome Treatment
    1 Other