BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE PRECISIONGLIDE 30X1/2IN

    MDR report key: 9263009 · Received October 31, 2019

    Report

    Report Number
    3003916417-2019-00548
    Event Type
    Malfunction
    Date Received
    October 31, 2019
    Date of Event
    October 16, 2019
    Report Date
    November 27, 2019
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWENTY-SIX (26) SAMPLES AND TWO (2) PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE RETURNED SAMPLES WERE VISUALLY EXAMINED FOR CLOGS. IT WAS OBSERVED THAT ALL THE RETURNED SAMPLES WERE CLOGGED AS LIGHT WAS NOT ABLE TO PASS THROUGH THE SAMPLES. IT WAS ALSO NOTED THAT ALL THE RETURNED SAMPLES HAVE BEEN OPENED BY PUSHING THE NEEDLE THROUGH THE BLISTER PACK RATHER THAN PEELING THE PACKAGING WEBS APART. TWO (2) PHOTOS WERE ALSO PROVIDED BY THE CUSTOMER FOR INVESTIGATION. ONE (1) PHOTO SHOWS AN UNSHIELDED NEEDLE ASSEMBLY. THE SECOND (2ND) PHOTO SHOWS A GROUP OF OPENED SAMPLES IN A CUP. ALL THE NEEDLE ASSEMBLIES IN THE PHOTO HAVE BEEN OPENED BY PUSHING THE NEEDLE THROUGH THE BLISTER PACK RATHER THAN PEELING THE PACKAGING WEBS APART. FOREIGN MATERIAL (FM) CAN BE INTRODUCED TO THE FLUID PATH DURING THE MANUFACTURING PROCESS WHICH COULD CAUSE THE NEEDLE TO BECOME CLOGGED. ALL PRODUCT IS AUTOMATICALLY CHECKED FOR CLOGGED NEEDLES DURING THE PRODUCTION PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE PRECISIONGLIDE 30X1/2IN EXPERIENCED CLOGGED/BLOCKED NEEDLES WHICH WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE PURCHASED BD NEEDLES (YELLOW 0.30X13 MM (30 G X 1/2 "- CX 100 PCS), HOWEVER SOME BOXES ARE COMING WITH NEEDLES WITHOUT PUNCTURE. ADDITIONAL INFORMATION: THE LOT NUMBER IS 9112781. THE CUSTOMER REPORTS THAT THE ISSUE IS "NEEDLE CLOGGED". THE INCIDENT WAS NOTICED BEFORE THE USE. THERE WAS NO DAMAGE TO THE PATIENT/HEALTH PROFESSIONAL. THE DRUG USED WAS ETHAMOLIN. THERE IS (B)(4) UNITS OF THE DEFECTIVE NEEDLE STOCKED.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF NEEDLE PRECISIONGLIDE 30X1/2IN EXPERIENCED CLOGGED/BLOCKED NEEDLES WHICH WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE PURCHASED BD NEEDLES (YELLOW 0.30X13 MM (30 G X 1/2 "- CX 100 PCS), HOWEVER SOME BOXES ARE COMING WITH NEEDLES WITHOUT PUNCTURE. ADDITIONAL INFORMATION: THE LOT NUMBER IS 9112781. THE CUSTOMER REPORTS THAT THE ISSUE IS "NEEDLE CLOGGED". THE INCIDENT WAS NOTICED BEFORE THE USE. THERE WAS NO DAMAGE TO THE PATIENT/HEALTH PROFESSIONAL. THE DRUG USED WAS ETHAMOLIN. THERE IS 24 UNITS OF THE DEFECTIVE NEEDLE STOCKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059055 NEEDLE PRECISIONGLIDE 30X1/2IN NEEDLE FMI BECTON DICKINSON IND. CIRURGICAS LTDA 9112781

    Patients

    Seq Age Sex Outcome Treatment
    1 Other