BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 18X1-1/2 SB

    MDR report key: 8732365 · Received June 25, 2019

    Report

    Report Number
    1911916-2019-00627
    Event Type
    Malfunction
    Date Received
    June 25, 2019
    Date of Event
    June 9, 2019
    Report Date
    July 31, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051992
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO (2) SAMPLES WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. ONE (1) SAMPLE WAS IN A BAGGIE LABELED ¿SAME LOT #. NOT DEFECTIVE. KEEP FOR COMPARISON / VERIFICATION PURPOSES¿. THE SECOND (2ND) SAMPLE WAS IN A BAGGIE LABELED ¿DEFECTIVE SAMPLE¿. THE NON-CONFORMING SAMPLE WAS SHOW TO QUALITY CONTROL REPRESENTATIVES WHO CONFIRMED THAT THE SAMPLE IS LACKING THE PROPER COLOR. THE QC REPRESENTATIVES ALSO NOTED THAT THE NEEDLE HUB ASSEMBLY HAD BEEN PUSHED INTO THE SHIELD SO FAR THAT THE SHIELD HAD CRACKED. DURING THE MOLDING PROCESS COLORANT IS MIXED WITH THE RESIN PRIOR TO MOLDING TO PROVIDE THE COLOR. THEREFORE SOME COLOR VARIATION IS NORMAL; HOWEVER, WHEN THE QUALITY CONTROL REPRESENTATIVES ANALYZED THE RETURN SAMPLE IT WAS DETERMINED THAT THIS NEEDLE HUB ASSEMBLY WAS TOO LIGHT AND SHOULD HAVE BEEN REJECTED IF SEEN BY AN OPERATOR. IT IS LIKELY THAT THE NEEDLE HUB ASSEMBLY WAS NOT SEEN IN PROCESS AND WAS THEREFORE NOT CULLED OUT. THE QUALITY CONTROL REPRESENTATIVES ALSO OBSERVED A CRACK IN THE NEEDLE SHIELD DUE TO THE NEEDLE SHIELD BEING PUSHING INTO THE SHIELD TOO FAR DUE TO A MACHINE MALFUNCTION WHEN THE NEEDLE SHIELD WAS BEING PLACED ON THE NEEDLE HUB ASSEMBLY. THIS RESULTED IN THE CONDITION OBSERVED BY THE CUSTOMER OF ¿THERE IS NO SPACE TO ACCOMMODATE THE ATTACHING OF THE HUB TO THE TIP OF THE SYRINGE.¿ 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO SAMPLES OR PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. BASED ON THE INVESTIGATION CONCLUSION AND WITHOUT A SAMPLE TO ANALYZE, THE CONDITIONS REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED NOR COULD THIS SYMPTOM BE CORRELATED WITH A POTENTIAL CAUSE LINKED TO THE BD PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE COULD NOT ATTACH TO SYRINGE, EITHER HUB TOOL SHORT OF NEEDLE CAP TOO LONG, ALSO, THE HUB WAS A DIFFERENT COLOR THAN THE REST OF THE LOT NUMBERS WITH A BD NEEDLE 18X1-1/2 SB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305199 BATCH NO. 8117703 . IT WAS REPORTED THAT THE NEEDLE WOULD NOT ATTACH TO THE SYRINGE AND IT WAS NOTED THAT THE NEEDLE HUB WAS A DIFFERENT COLOR FROM THE REST OF THE LOT NUMBERS. PER INITIAL REPORTER EMAIL: ¿ COULD NOT ATTACH THE NEEDLE TO THE SYRINGE. IT APPEARS THE HUB IS TOO SHORT OR THE NEEDLE CAP IS TOO LONG AND THERE IS NO SPACE TO ACCOMMODATE THE ATTACHING OF THE HUB TO THE TIP OF THE SYRINGE. THE NEEDLE HUB IS A DIFFERENT COLOUR THAN OTHERS OF THE SAME LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE COULD NOT ATTACH TO SYRINGE, EITHER HUB TOOL SHORT OF NEEDLE CAP TOO LONG, ALSO, THE HUB WAS A DIFFERENT COLOR THAN THE REST OF THE LOT NUMBERS WITH A BD NEEDLE 18X1-1/2 SB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305199 BATCH NO. 8117703 IT WAS REPORTED THAT THE NEEDLE WOULD NOT ATTACH TO THE SYRINGE AND IT WAS NOTED THAT THE NEEDLE HUB WAS A DIFFERENT COLOR FROM THE REST OF THE LOT NUMBERS. PER INITIAL REPORTER EMAIL: COULD NOT ATTACH THE NEEDLE TO THE SYRINGE. IT APPEARS THE HUB IS TOO SHORT OR THE NEEDLE CAP IS TOO LONG AND THERE IS NO SPACE TO ACCOMMODATE THE ATTACHING OF THE HUB TO THE TIP OF THE SYRINGE. THE NEEDLE HUB IS A DIFFERENT COLOUR THAN OTHERS OF THE SAME LOT NUMBER.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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 NEEDLE COULD NOT ATTACH TO SYRINGE, EITHER HUB TOOL SHORT OF NEEDLE CAP TOO LONG, ALSO, THE HUB WAS A DIFFERENT COLOR THAN THE REST OF THE LOT NUMBERS WITH A BD NEEDLE 18X1-1/2 SB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305199, BATCH NO. 8117703. IT WAS REPORTED THAT THE NEEDLE WOULD NOT ATTACH TO THE SYRINGE AND IT WAS NOTED THAT THE NEEDLE HUB WAS A DIFFERENT COLOR FROM THE REST OF THE LOT NUMBERS. PER INITIAL REPORTER EMAIL: ¿ COULD NOT ATTACH THE NEEDLE TO THE SYRINGE. IT APPEARS THE HUB IS TOO SHORT OR THE NEEDLE CAP IS TOO LONG AND THERE IS NO SPACE TO ACCOMMODATE THE ATTACHING OF THE HUB TO THE TIP OF THE SYRINGE. THE NEEDLE HUB IS A DIFFERENT COLOUR THAN OTHERS OF THE SAME LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526633 BD NEEDLE 18X1-1/2 SB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 8117703 30382903051992

    Patients

    Seq Age Sex Outcome Treatment
    1 Other