BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE, PLASTIC, W/ NEEDLE 1CC 25GX5/8

    MDR report key: 10752442 · Received October 28, 2020

    Report

    Report Number
    3003916417-2020-00327
    Event Type
    Malfunction
    Date Received
    October 28, 2020
    Date of Event
    October 5, 2020
    Report Date
    November 9, 2020
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: LOT NUMBER IS UNKNOWN; THEREFORE, LOT HISTORY COULD NOT BE PERFORMED. NO SAMPLES OF REPORTED INCIDENT WERE RECEIVED FOR ANALYSIS. THE PICTURES PROVIDED DO NOT ALLOW TO EVALUATE THE REPORTED INCIDENT. THE MANUFACTURING PROCESS ARE VALIDATED WITH DEFINED ACCEPTANCE CRITERIA. FROM THIS INFORMATION IT IS NOT POSSIBLE CONFIRM THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE, PLASTIC, W/ NEEDLE 1CC 25GX5/8 SEPARATED FROM THE NEEDLE DURING THE IMMUNOTHERAPY PROCEDURE. THIS OCCURRED 20 TIMES IN A "TWO MONTH" PERIOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: "DR. PERFORMS IMMUNOTHERAPY PROCEDURE WITH ULTRA-FINE BD INSULIN SYRINGES (CATALOG 326732) THAT HAS A NEEDLE ATTACHED TO THE SYRINGE AND TO PERFORM THE INTRODERMAL REACTION PROCEDURE SHE USES A 1 ML TUBERCULIN SYRINGE WITH A DETACHABLE NEEDLE. ON MANY OCCASIONS, DR. HAS HAD TO PUNCTURE 2 TIMES IN THE PROCEDURES, SINCE THEY HAVE HAD TO USE 1 ML TUBERCULIN SYRINGES (CATALOG 990214) FOR BOTH PROCEDURES. THEY MENTION THAT CATALOG 990214 HAS A THICKNESS AND LENGTH OF THE NEEDLE THAT IS NOT INDICATED. DUE TO THE PRESSURE EXERTED ON THE TUBERCULIN LUER SLIP SYRINGE, THE NEEDLE COMES OUT OF THE SYRINGE." "THE SALES REP CLARIFIED THAT THE CUSTOMER DOES NOT HAVE THE LOT INFORMATION SINCE THIS IS A SITUATION THAT IS HAPPENING FOR THE LAST TWO MONTHS. SHE THINKS THE CUSTOMER IS DISSATISFIED BECAUSE THEY RECEIVED THE WRONG PRODUCT FROM THE DISTRIBUTOR."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE, PLASTIC, W/ NEEDLE 1CC 25GX5/8 SEPARATED FROM THE NEEDLE DURING THE IMMUNOTHERAPY PROCEDURE. THIS OCCURRED 20 TIMES IN A "TWO MONTH" PERIOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: "DR. PERFORMS IMMUNOTHERAPY PROCEDURE WITH ULTRA-FINE BD INSULIN SYRINGES (CATALOG 326732) THAT HAS A NEEDLE ATTACHED TO THE SYRINGE AND TO PERFORM THE INTRODERMAL REACTION PROCEDURE SHE USES A 1 ML TUBERCULIN SYRINGE WITH A DETACHABLE NEEDLE. ON MANY OCCASIONS, DR. HAS HAD TO PUNCTURE 2 TIMES IN THE PROCEDURES, SINCE THEY HAVE HAD TO USE 1 ML TUBERCULIN SYRINGES (CATALOG 990214) FOR BOTH PROCEDURES. THEY MENTION THAT CATALOG 990214 HAS A THICKNESS AND LENGTH OF THE NEEDLE THAT IS NOT INDICATED. DUE TO THE PRESSURE EXERTED ON THE TUBERCULIN LUER SLIP SYRINGE, THE NEEDLE COMES OUT OF THE SYRINGE." "THE SALES REP CLARIFIED THAT THE CUSTOMER DOES NOT HAVE THE LOT INFORMATION SINCE THIS IS A SITUATION THAT IS HAPPENING FOR THE LAST TWO MONTHS. SHE THINKS THE CUSTOMER IS DISSATISFIED BECAUSE THEY RECEIVED THE WRONG PRODUCT FROM THE DISTRIBUTOR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1217789 SYRINGE, PLASTIC, W/ NEEDLE 1CC 25GX5/8 PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1