BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G

    MDR report key: 8575835 · Received May 2, 2019

    Report

    Report Number
    9616656-2019-00409
    Event Type
    Malfunction
    Date Received
    May 2, 2019
    Date of Event
    April 17, 2019
    Report Date
    June 12, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403811012
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCE'S WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: CUSTOMER RETURNED (1) USED 31G X 5MM BD PEN NEEDLE WITHOUT A TEAR DROP LABEL ATTACHED. CONSUMER REPORTED 1 SAMPLE OF 320119 THAT WOULD NOT ALLOW INSULIN THRU IT ON 2 DIFFERENT PENS DURING INJECTION ATTEMPT. THE RETURNED SAMPLE WAS TESTED FOR FLOW USING A TEST PEN INJECTOR: THE RETURNED SAMPLE FAILED THE FLOW TEST. A WIRE TEST WAS THEN PERFORMED ON THE SAMPLE: THE WIRE PASSED THROUGH THE CANNULA; HOWEVER, THERE WAS A SMALL, CLEAR RESIDUE OBSERVED AT THE TIP OF THE WIRE AFTER BEING THROUGH THE CANNULA. UNDER THE MICROSCOPE THE RESIDUE WAS IDENTIFIED AS RESIDUAL SILICONE FROM THE MANUFACTURING PROCESS. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. THE POSSIBLE ROOT CAUSE FOR THIS ISSUE: SOME RESIDUAL SILICONE FROM THE MANUFACTURING LUBRICATION PROCESS COULD BE THE CAUSE FOR SLIGHT BLOCKAGE OF THE FLOW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G EXPERIENCED AN INABILITY TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320119 BATCH NO: 8241504 IT WAS REPORTED THAT CONSUMER'S NEEDLE WOULD NOT ALLOW INSULIN THRU IT. VERBATIM: FROM PHONE CALL ON (B)(6) 2019 09:34:21: CONSUMER CALLED IN RESPONSE TO EMAIL. HAS 1 SAMPLE OF 320119 THAT WOULD NOT ALLOW INSULIN THRU IT ON 2 DIFFERENT PENS DURING INJECTION ATTEMPT. INFORMED CONSUMER OF PROPER PLACEMENT OF NON PATIENT END AND TO COMPLETE A FLOW CHECK BEFORE ALL INJECTIONS. DC EMAIL RECEIVED: EMAIL SENT (B)(6) 2019 10:37:26 I HAD A NEEDLE TODAY THAT WOULD NOT ALLOW INSULIN THROUGH. I WANTED TO REPORT IN CASE IT WAS PART OF A LARGER ISSUE. THE LOT # IS 8241504 EXPIRATION 2023-08-31 BD PEN ULTRA FINE NDL 5MM MINI NEEDLES 31GX5MM(3/16)PRPL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G EXPERIENCED AN INABILITY TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320119 BATCH NO: 8241504 IT WAS REPORTED THAT CONSUMER'S NEEDLE WOULD NOT ALLOW INSULIN THRU IT. VERBATIM: FROM PHONE CALL ON (B)(6) 2019 09:34:21: CONSUMER CALLED IN RESPONSE TO EMAIL. HAS 1 SAMPLE OF 320119 THAT WOULD NOT ALLOW INSULIN THRU IT ON 2 DIFFERENT PENS DURING INJECTION ATTEMPT. INFORMED CONSUMER OF PROPER PLACEMENT OF NON PATIENT END AND TO COMPLETE A FLOW CHECK BEFORE ALL INJECTIONS. DC EMAIL RECEIVED: EMAIL SENT (B)(6) 2019 10:37:26 I HAD A NEEDLE TODAY THAT WOULD NOT ALLOW INSULIN THROUGH. I WANTED TO REPORT IN CASE IT WAS PART OF A LARGER ISSUE. THE LOT # IS 8241504 EXPIRATION 2023-08-31 BD PEN ULTRA FINE NDL 5MM MINI NEEDLES 31GX5MM(3/16)PRPL.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G EXPERIENCED AN INABILITY TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320119, BATCH NO: 8241504. IT WAS REPORTED THAT CONSUMER'S NEEDLE WOULD NOT ALLOW INSULIN THRU IT. VERBATIM: FROM PHONE CALL ON (B)(6) 2019, 09:34:21: CONSUMER CALLED IN RESPONSE TO EMAIL. HAS 1 SAMPLE OF 320119 THAT WOULD NOT ALLOW INSULIN THRU IT ON 2 DIFFERENT PENS DURING INJECTION ATTEMPT. INFORMED CONSUMER OF PROPER PLACEMENT OF NON PATIENT END AND TO COMPLETE A FLOW CHECK BEFORE ALL INJECTIONS. DC EMAIL RECEIVED: EMAIL SENT: (B)(6) 2019, 10:37:26. I HAD A NEEDLE TODAY THAT WOULD NOT ALLOW INSULIN THROUGH. I WANTED TO REPORT IN CASE IT WAS PART OF A LARGER ISSUE. THE LOT # IS 8241504. EXPIRATION 2023-08-31. BD PEN ULTRA FINE NDL 5MM MINI NEEDLES 31GX5MM(3/16)PRPL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369646 BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8241504 10885403811012

    Patients

    Seq Age Sex Outcome Treatment
    1 Other