BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE III PEN NEEDLE

    MDR report key: 11599709 · Received March 31, 2021

    Report

    Report Number
    9616656-2021-00336
    Event Type
    Malfunction
    Date Received
    March 31, 2021
    Date of Event
    March 5, 2021
    Report Date
    May 12, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 9183079. D.4. MEDICAL DEVICE EXPIRATION DATE: 7/31/2024. H.4. DEVICE MANUFACTURE DATE: 7/2/2019. D.4. MEDICAL DEVICE LOT #: UNKNOWN. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 4/29/2021. H.6. INVESTIGATION: CUSTOMER RETURNED (19) 8MM, 31G PEN NEEDLES (4 OPEN, 15 SEALED) WITH THE SHELF CARTON FROM LOT # 9183079. NO SAMPLES FROM AN UNKNOWN LOT NUMBER WERE RETURNED. CUSTOMER STATES THAT THE NEEDLE BENT, AND THAT ONE PEN NEEDLE WAS WITHOUT A SUITABLE TIP THAT SANK INTO THE SKIN WITHOUT PENETRATION. ALL RETURNED PEN NEEDLES WERE EXAMINED AND 2 OUT OF 4 OPEN SAMPLES EXHIBITED A BENT PATIENT END OF THE CANNULA. NO BENT CANNULA WAS OBSERVED ON ANY OF THE SEALED SAMPLES. ALL RETURNED PEN NEEDLES WERE TESTED FOR POINT GEOMETRY, LUBE, AND CANNULA OD. TWO OF THE OPEN SAMPLES EXHIBITED A HOOKED CANNULA POINT ON THE PATIENT END. 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 AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. ROOT CAUSE IS USER RELATED. THE CANNULA POINT OF THE PATIENT END WAS HOOKED DURING USE OF THE PRODUCT BY THE CUSTOMER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD ULTRA-FINE¿ III PEN NEEDLES IN AN UNSPECIFIED LOT WERE CLOGGED AND WOULDN'T PRIME, AND ANOTHER NEEDLE IN AN UNSPECIFIED LOT HAD MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: "THE BOX IN QUESTION MUST HAVE BEEN OPENED IN MID-FEBRUARY AND I HAVE 37 NEW NEEDLES AND 2 FAILED TODAY (ONE BENT AND ONE WITHOUT A SUITABLE TIP THAT SANK INTO THE SKIN WITHOUT PENETRATE) WHICH WAS WHEN I LOOKED AGAIN AT THE BOX IF THERE WAS WHERE TO CLAIM AND I FOUND THE 0800, BEFORE I FOUND 3 NEEDLES WITH TIPS BENT TO DIFFERENT DEGREES (ONE BENT IN A U) BUT SINCE I DID NOT SEE THE 0800 I THREW THEM AWAY. UNTIL NOW I HAVE NEVER HAD A STRING OF FAILED NEEDLES, I ONLY EVER FOUND FAILED TIPS AND 1 TIME A CLOGGED ONE X WHICH FROM THAT MOMENT I TEST IF THE DROP APPEARS WITH 1 UNIT."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. NO DHR REVIEW CAN BE CARRIED OUT AS LOT NUMBER IS UNKNOWN. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA/SA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD ULTRA-FINE¿ III PEN NEEDLES IN AN UNSPECIFIED LOT WERE CLOGGED AND WOULDN'T PRIME, AND ANOTHER NEEDLE IN AN UNSPECIFIED LOT HAD MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE BOX IN QUESTION MUST HAVE BEEN OPENED IN MID-FEBRUARY AND I HAVE 37 NEW NEEDLES AND 2 FAILED TODAY (ONE BENT AND ONE WITHOUT A SUITABLE TIP THAT SANK INTO THE SKIN WITHOUT PENETRATE) WHICH WAS WHEN I LOOKED AGAIN AT THE BOX IF THERE WAS WHERE TO CLAIM AND I FOUND THE 0800, BEFORE I FOUND 3 NEEDLES WITH TIPS BENT TO DIFFERENT DEGREES (ONE BENT IN A U) BUT SINCE I DID NOT SEE THE 0800 I THREW THEM AWAY. UNTIL NOW I HAVE NEVER HAD A STRING OF FAILED NEEDLES, I ONLY EVER FOUND FAILED TIPS AND 1 TIME A CLOGGED ONE X WHICH FROM THAT MOMENT I TEST IF THE DROP APPEARS WITH 1 UNIT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495507 BD ULTRA-FINE III PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 9183079

    Patients

    Seq Age Sex Outcome Treatment
    1