BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD¿ NANO ULTRA-FINE PEN NEEDLE

    MDR report key: 8204215 · Received December 28, 2018

    Report

    Report Number
    9616656-2018-00347
    Event Type
    Injury
    Date Received
    December 28, 2018
    Date of Event
    December 11, 2018
    Report Date
    January 25, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403897511
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE CONSUMER EXPERIENCED BRUISING AND BLEEDING AFTER INJECTING WHEN USING BD¿ NANO ULTRA-FINE PEN NEEDLES. THE CONSUMER ADDRESSED THIS ISSUE WITH HER DOCTOR DURING HER NEXT VISIT. IN SECTION H.10 OF THE PREVIOUSLY SUBMITTED MDR, SECTIONS D.1 WAS INCORRECTLY REFERENCED AS THE MEDICAL DEVICE EXPIRATION DATE AND DEVICE MANUFACTURE DATE. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO CORRECT THOSE REFERENCES TO SHOW THE FOLLOWING: MEDICAL DEVICE EXPIRATION DATE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED ( 5 ) 4MM, 32G SEALED BD PEN NEEDLES. CUSTOMER REPORTS BRUISING AND BLEEDING AFTER SHE INJECTS. ALL 5 RETURNED PEN NEEDLES WERE TESTED FOR POINT GEOMETRY, OUTER DIAMETER AND LUBE COVERAGE. THE FOLLOWING WAS OBSERVED (SPECS: OUTER DIAMETER FOR 32G: 0.0090¿- 0.0095¿): DATA: POINT (PE/NPE) OUTER DIAMETER (IN) LUBE SAMPLE 1: GOOD/GOOD. 0.0090; GOOD. SAMPLE 2: GOOD/GOOD. 0.0090; GOOD. SAMPLE 3: GOOD/GOOD. 0.0091; GOOD. SAMPLE 4: GOOD/GOOD. 0.0091; GOOD. SAMPLE 5: GOOD/GOOD. 0.0090; GOOD. 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. BASED ON THE SAMPLES / PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. 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. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONSUMER EXPERIENCED BRUISING AND BLEEDING AFTER INJECTING WHEN USING BD¿ NANO ULTRA-FINE PEN NEEDLES. THE CONSUMER ADDRESSED THIS ISSUE WITH HER DOCTOR DURING HER NEXT VISIT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONSUMER EXPERIENCED BRUISING AND BLEEDING AFTER INJECTING WHEN USING BD¿ NANO ULTRA-FINE PEN NEEDLES. THE CONSUMER ADDRESSED THIS ISSUE WITH HER DOCTOR DURING HER NEXT VISIT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: N/A. 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

    "T" WAS REPORTED THAT THE CONSUMER EXPERIENCED BRUISING AND BLEEDING AFTER INJECTING WHEN USING BD¿ NANO ULTRA-FINE PEN NEEDLES. THE CONSUMER ADDRESSED THIS ISSUE WITH HER DOCTOR DURING HER NEXT VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042453 BD¿ NANO ULTRA-FINE PEN NEEDLE AUTOINJECTOR NEEDLE FMI BECTON DICKINSON AND CO. 8010989 10885403897511

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention