BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE SST PLH 13X75 3.5 PLBL GOLD BRBLOOD SPECIMEN COLLECTION DEVICE

    MDR report key: 15798148 · Received November 15, 2022

    Report

    Report Number
    3003916417-2022-00252
    Event Type
    Malfunction
    Date Received
    November 15, 2022
    Date of Event
    October 31, 2022
    Report Date
    December 15, 2022
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    JKA
    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

    THIS SUPPLEMENTAL WAS CREATED TO CANCEL THE MDR 6557327 MFR 3003916417-2022-00252. BD DISTRIBUTION CENTER RECEIVED THE CARTON WITH LABEL 2151244, AND REPORTED IT TO LARCC AS A NEW COMPLAINT, CAPTURED BY (B)(4). IN CONTACT WITH CUSTOMER, CUSTOMER SERVICE KEY ACCOUNT ANALYST HAS GOTTEN THE CONFIRMATION THAT THERE IS NO ISSUE ASSOCIATED TO BATCH 2151244. ON 14.DEC.2022, BD DC OPENED THE CARTON AND FOUND MATERIAL BATCH 2120755 INSIDE, WHICH CONFIRMS THE STATEMENT ABOVE. THEREFORE, THE MATERIAL RECEIVED REGARDS TO (B)(4), AND THERE IS NO COMPLAINT ASSOCIATED TO BATCH 2151244. THUS THIS RECORD SHALL BE CANCELLED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 0

    IT WAS REPORTED WHEN USING THE BD TUBE SST PLH 13X75 3.5 PLBL GOLD BRBLOOD SPECIMEN COLLECTION DEVICE, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD AND AIR BUBBLES IN THE GEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: CUSTOMER HAS FACING ISSUES WITH THE GEL TUBE. THE VACUUM IS TOO WEAK (DECREASED), AND THE GEL IS FULL OF BUBBLES. IT HAS BEEN ALLEGEDLY REPORTED TO SURVEILLANCE, BUT CUSTOMER HAS PUT MATERIAL IN QUARANTINE. INFORMATION RECEIVED: DUE TO (B)(4), CUSTOMER REQUIRED TO RETURN THE MATERIAL BATCH # 2120755 TO BD. HOWEVER, AT THAT MOMENT, CUSTOMER NO LONGER HAD ITS ORIGINAL CARTON, AND THEREFORE THEY'VE PACKED THE BATCH 2120755 WITHIN A DIFFERENT CARTON (WHICH LABEL SHOWS BATCH 2151244). BD DISTRIBUTION CENTER RECEIVED THE CARTON WITH LABEL 2151244, AND REPORTED IT TO LARCC AS A NEW COMPLAINT, CAPTURED BY (B)(4). IN CONTACT WITH CUSTOMER, CUSTOMER SERVICE KEY ACCOUNT ANALYST HAS GOTTEN THE CONFIRMATION THAT THERE IS NO ISSUE ASSOCIATED TO BATCH 2151244. ON 14.DEC.2022, BD DC OPENED THE CARTON AND FOUND MATERIAL BATCH 2120755 INSIDE, WHICH CONFIRMS THE STATEMENT ABOVE. THEREFORE, THE MATERIAL RECEIVED REGARDS TO (B)(4), AND THERE IS NO COMPLAINT ASSOCIATED TO BATCH 2151244. THUS THIS RECORD SHALL BE CANCELLED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD TUBE SST PLH 13X75 3.5 PLBL GOLD BRBLOOD SPECIMEN COLLECTION DEVICE, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD AND AIR BUBBLES IN THE GEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: CUSTOMER HAS FACING ISSUES WITH THE GEL TUBE. THE VACUUM IS TOO WEAK (DECREASED), AND THE GEL IS FULL OF BUBBLES. IT HAS BEEN ALLEGEDLY REPORTED TO SURVEILLANCE, BUT CUSTOMER HAS PUT MATERIAL IN QUARANTINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021010 TUBE SST PLH 13X75 3.5 PLBL GOLD BRBLOOD SPECIMEN COLLECTION DEVICE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA 2151244

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown