BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA FINE PEN NEEDLES

    MDR report key: 10597993 · Received September 29, 2020

    Report

    Report Number
    9616656-2020-00968
    Event Type
    Injury
    Date Received
    September 29, 2020
    Date of Event
    September 13, 2020
    Report Date
    September 28, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403801518
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: LEVEL B INVESTIGATION. COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S3; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST. RELATED COMPLAINT FOR NEEDLE BREAKS OFF DURING USE PE ON LOT # 0022816. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A REVIEW OF RISK MANAGEMENT DOCUMENT (B)(4), INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (PEN NEEDLE, NEEDLE BREAKS OFF DURING USE) WAS CAPTURED AND ADDRESSED. 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. INVESTIGATION CONCLUSION: 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRA FINE¿ PEN NEEDLE CANNULA BROKE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320109, BATCH NO: 0022816. IT WAS REPORTED CONSUMER REPORTED THE NEEDLE BREAK WAS IN HER ARM. VERBATIM: CONSUMER CALLING TO UPDATE THE FILE. HAD A THIRD X-RAY COMPLETED YESTERDAY THEY COULD NOT FIND WITH X-RAY. THEY NOW WOULD LIKE EXPLORE REVIEW WITHIN HER ARM. SHE DOES NOT KNOW WHAT THIS MEANS. STRONGLY FEELS THE NEEDLE IS IN SITE, HOWEVER NO VISIBLE BUMP ON SKIN. SHE IS WAITING FOR INSURANCE TO SAY IF THIS PROCEDURE IS COVERED OR NOT. (B)(4). CONSUMER CALLING BACK TO INFORM DOCTORS REVIEW WAS THAT X-RAY DID NOT SHOW THE NEEDLE. THIS CONSUMER STRONGLY FEELS HERSELF THAT IT TRAVELED. DOCTOR STATED HE WILL COMPLETE A 3RD X-RAY BUT THIS TIME ON HER ELBOW. WITH A POSSIBLE DATE TO REMOVE WHEN IT LOCATED ON (B)(6) 2020. FROM PHONE CALL ON (B)(6) 2020 10:49:47: CONSUMER CALLED BACK OUR OUTGOING VOICE MESSAGE. CONSUMER REPORTED THE NEEDLE BREAK WAS IN HER ARM. SHE WENT TO A PATIENT CARE FACILITY THEY COMPLETED AN X-RAY. SAID THEY COULD SEE NEEDLE ON X-RAY. INFORMED THIS CONSUMER TO VISIT SURGEON. THIS 2ND DOCTOR COMPLETED HIS OWN X-RAY (2ND X-RAY) TO PIN POINT THE LOCATION ON (B)(6) 2020. THIS 2ND ONE DID NOT LOCATE THE NEEDLE. THEY SENT HER HOME (B)(6) 2020. THIS 2ND DOCTOR SHOULD BE CALLING HER WITH UPDATES BY (B)(6) 2020. CONSUMER DENIED REUSE OF NEEDLE. I ALSO ASKED IF SHE PRIMED THE NEEDLE BEFORE INJECTION SHE SAID YES. REVIEWED WITH THIS CONSUMER THE NEED FOR THE EOB, MEDICAL RECEIPTS, AND RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064272 BD ULTRA FINE PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8015 0022816 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention