BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE INSULIN PEN NEEDLE

    MDR report key: 9675301 · Received February 6, 2020

    Report

    Report Number
    9616656-2020-00081
    Event Type
    Malfunction
    Date Received
    February 6, 2020
    Date of Event
    January 13, 2020
    Report Date
    May 28, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903282036
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 5/19/2020. H.6. INVESTIGATION: CUSTOMER RETURNED EIGHT (8) SEALED/UNUSED 29GX12.7MM BD PEN NEEDLES FROM LOT 9163452. CONSUMER REPORTED THAT THE BOX OF PEN NEEDLES SHE PURCHASED ON 01-13-2020 HAS A PHARMACY LABEL THAT SHOWS AN EXPIRATION DATE OF 04-27-10 AND HURT DURING INJECTION. ALL EIGHT RETURNED PEN NEEDLES WERE EXAMINED, THEN TESTED FOR VISUAL INSPECTION OF POINT GEOMETRY, OUTER DIAMETER AND LUBE COVERAGE. THE FOLLOWING WAS OBSERVED (SPECS: OUTER DIAMETER FOR 29G: 0.0130¿- 0.0135¿): DATA: POINT (PE/NPE): OUTER DIAMETER (IN): LUBE: SAMPLE 1, GOOD/GOOD, 0.0132, GOOD. SAMPLE 2, GOOD/GOOD, 0.0132, GOOD. SAMPLE 3, GOOD/GOOD, 0.0132, GOOD. SAMPLE 4, GOOD/GOOD, 0.0132, GOOD. SAMPLE 5, GOOD/GOOD, 0.0132, GOOD. SAMPLE 6, GOOD/GOOD, 0.0132, GOOD. SAMPLE 7, GOOD/GOOD, 0.0132, GOOD. SAMPLE 8, GOOD/GOOD, 0.0132, GOOD. ALL EIGHT PEN NEEDLES TESTED WITHIN SPECIFICATION. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. SINCE NO DEFECTS WERE OBSERVED THE ALLEGED ISSUES COULD NOT BE CONFIRMED. AS PER MANUFACTURING: DHRS ARE LEGALLY KEPT FOR 7 YEARS AFTER THE BATCH CREATION DATE. LOT NUMBER 9163452 WAS MANUFACTURED ON AUGUST 2009 (10 YEARS SINCE BATCH CREATION DATE), THUS THE DHR FOR THIS LOT NUMBER IS NO LONGER AVAILABLE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: LOT # 9163452 WAS MANUFACTURED IN 2009 AND THE PRODUCT HAS SINCE EXPIRED AND SHOULD NO LONGER BE USED. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THE DHR REQUEST FOR EXPIRED PRODUCT CANNOT BE PERFORMED BASED UPON THE AGE OF THE LOT # 9163452. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA-FINE¿ INSULIN PEN NEEDLE WAS EXPIRED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 328203, BATCH NO.: 9163452. IT WAS REPORTED BY THE CONSUMER THAT THE BOX OF PEN NEEDLES SHE PURCHASED ON 01-13-2020 HAS A PHARMACY LABEL THAT SHOWS AN EXPIRATION DATE OF 04-27-10 AND HURT DURING INJECTION. VERBATIM: CONSUMER CALLED TO INQUIRE ABOUT PEN NEEDLES THAT SHE PURCHASED ON 01-13-2020. SHE STATED THAT THERE IS A PHARMACY LABEL ON THE BOX SHOWING EXPIRATION DATE 04-27-10. CONSUMER SAID THAT THE NEEDLES HURT DURING INJECTION, DOES NOT RE-USE. NO MEDICAL ATTENTION, NO INJURY OR DISCOMFORT. SAMPLES WILL BE SUBMITTED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA-FINE¿ INSULIN PEN NEEDLE WAS EXPIRED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 328203 . BATCH NO.: 9163452. IT WAS REPORTED BY THE CONSUMER THAT THE BOX OF PEN NEEDLES SHE PURCHASED ON (B)(6) 2020 HAS A PHARMACY LABEL THAT SHOWS AN EXPIRATION DATE OF 04-27-10 AND HURT DURING INJECTION. VERBATIM: CONSUMER CALLED TO INQUIRE ABOUT PEN NEEDLES THAT SHE PURCHASED ON (B)(6) 2020. SHE STATED THAT THERE IS A PHARMACY LABEL ON THE BOX SHOWING EXPIRATION DATE 04-27-10. CONSUMER SAID THAT THE NEEDLES HURT DURING INJECTION, DOES NOT RE-USE. NO MEDICAL ATTENTION, NO INJURY OR DISCOMFORT. SAMPLES WILL BE SUBMITTED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: N/A. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ULTRA-FINE¿ INSULIN PEN NEEDLE WAS EXPIRED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 328203 BATCH NO.: 9163452. IT WAS REPORTED BY THE CONSUMER THAT THE BOX OF PEN NEEDLES SHE PURCHASED ON (B)(6) 2020 HAS A PHARMACY LABEL THAT SHOWS AN EXPIRATION DATE OF 04-27-10 AND HURT DURING INJECTION. VERBATIM: CONSUMER CALLED TO INQUIRE ABOUT PEN NEEDLES THAT SHE PURCHASED ON (B)(6) 2020. SHE STATED THAT THERE IS A PHARMACY LABEL ON THE BOX SHOWING EXPIRATION DATE 04-27-10. CONSUMER SAID THAT THE NEEDLES HURT DURING INJECTION, DOES NOT RE-USE. NO MEDICAL ATTENTION, NO INJURY OR DISCOMFORT. SAMPLES WILL BE SUBMITTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142898 BD ULTRA-FINE INSULIN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 328203 9163452 00382903282036

    Patients

    Seq Age Sex Outcome Treatment
    1 Other