BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 10171114 · Received June 18, 2020

    Report

    Report Number
    9616656-2020-00561
    Event Type
    Injury
    Date Received
    June 18, 2020
    Date of Event
    May 26, 2020
    Report Date
    June 30, 2020
    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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL?: YES. RETURNED TO MANUFACTURER ON: 6/29/2020. INVESTIGATION: CUSTOMER RETURNED (1) OPEN 5MM, 31G PEN NEEDLES WITHOUT THE TEAR DROP LABEL OR INNER SHIELD. CUSTOMER STATES THAT THE PEN NEEDLE DOES NOT RELEASE INSULIN DURING INJECTIONS, THE BLOOD SUGAR IS HIGH, THERE IS PAIN DURING THE INJECTION, AND THE NEEDLE WAS BENT AFTER THE INJECTION. THE RETURNED PEN NEEDLE WAS EXAMINED AND EXHIBITED A BENT NON PATIENT END OF THE CANNULA. THE SAMPLE WAS ALSO TESTED FOR POINT GEOMETRY, LUBE, AND CANNULA OD (SPECS: OUTER DIAMETER FOR 31G: 0.0100¿-0.0105¿). THE POINT EXHIBITED PROPER GEOMETRY, THE OD WAS MEASURED AS 0.0101¿, AND SUFFICIENT LUBE WAS OBSERVED. THE SAMPLE WAS ALSO TESTED AND WAS ABLE TO EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. 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 AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BENT CANNULA) UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (CLOG, PAIN, GLUCOSE LEVEL) CANNULA BENT DURING USE OF THE PRODUCT BY THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G WAS UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CUSTOMER'S PEN NEEDLE DO NOT RELEASE INSULIN DURING INJECTIONS, HIS BLOOD SUGAR HAS BEEN HAS BEEN ABOUT 30 POINTS HIGHER THEN WHAT IT USUALLY IS, HE EXPERIENCED PAIN DURING HIS INJECTION WITH ONE PEN NEEDLE AND HE THEN NOTICED THE PEN NEEDLE WAS COMPLETELY BENT AFTER HIS INJECTION. VERBATIM: CONSUMER REPORTED HAVING PEN NEEDLES THAT DO NOT RELEASE INSULIN DURING INJECTIONS. STATED HE DOES NOT PRIME BEFORE INJECTIONS. STATED HIS BLOOD SUGAR HAS BEEN HAS BEEN ABOUT 30 POINTS HIGHER THEN WHAT IT USUALLY IS. ADVISED CONSUMER THAT IT IS RECOMMENDED TO PRIME BEFORE EVERY INJECTION TO ENSURE PROPER MEDICATION FLOW. CONSUMER REPORTED LAST NIGHT ON 05/26/20 HE EXPERIENCED PAIN DURING HIS INJECTION WITH ONE PEN NEEDLE. STATED HE THEN NOTICED THE PEN NEEDLE WAS COMPLETELY BENT AFTER HIS INJECTION. STATED HE DOES NOT CHECK THE PEN NEEDLES PRIOR TO INJECTIONS TO ENSURE THEY ARE STRAIGHT. ADVISED CONSUMER TO ALWAYS CHECK THE NPE AND PE OF THE PEN NEEDLES TO ENSURE IT IS STRAIGHT BEFORE INJECTIONS. "

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRA-FINE¿ MINI PEN NEEDLES 5MM (3/16¿) 31G WAS UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CUSTOMER'S PEN NEEDLE DO NOT RELEASE INSULIN DURING INJECTIONS, HIS BLOOD SUGAR HAS BEEN HAS BEEN ABOUT 30 POINTS HIGHER THEN WHAT IT USUALLY IS, HE EXPERIENCED PAIN DURING HIS INJECTION WITH ONE PEN NEEDLE AND HE THEN NOTICED THE PEN NEEDLE WAS COMPLETELY BENT AFTER HIS INJECTION. VERBATIM: CONSUMER REPORTED HAVING PEN NEEDLES THAT DO NOT RELEASE INSULIN DURING INJECTIONS. STATED HE DOES NOT PRIME BEFORE INJECTIONS. STATED HIS BLOOD SUGAR HAS BEEN HAS BEEN ABOUT 30 POINTS HIGHER THEN WHAT IT USUALLY IS. ADVISED CONSUMER THAT IT IS RECOMMENDED TO PRIME BEFORE EVERY INJECTION TO ENSURE PROPER MEDICATION FLOW. CONSUMER REPORTED LAST NIGHT ON (B)(6) 2020 HE EXPERIENCED PAIN DURING HIS INJECTION WITH ONE PEN NEEDLE. STATED HE THEN NOTICED THE PEN NEEDLE WAS COMPLETELY BENT AFTER HIS INJECTION. STATED HE DOES NOT CHECK THE PEN NEEDLES PRIOR TO INJECTIONS TO ENSURE THEY ARE STRAIGHT. ADVISED CONSUMER TO ALWAYS CHECK THE NPE AND PE OF THE PEN NEEDLES TO ENSURE IT IS STRAIGHT BEFORE INJECTIONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635386 BD ULTRA-FINE MINI PEN NEEDLES 5MM (3/16) 31G HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8110 9288432 10885403811012

    Patients

    Seq Age Sex Outcome Treatment
    1 Other