BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE

    MDR report key: 8442046 · Received March 21, 2019

    Report

    Report Number
    9616656-2019-00270
    Event Type
    Malfunction
    Date Received
    March 21, 2019
    Date of Event
    March 6, 2019
    Report Date
    March 26, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903295159
    PMA / PMN Number
    K110007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (8) BD AUTO SHIELD DUO SAFETY PEN NEEDLES (USED). CONSUMER STATES THAT HIS AUTOSHIELD DUO PEN NEEDLES WERE NOT PUNCTURING THE SKIN AS THEY SHOULD, GET JAMMED/MALFUNCTIONING. ALL RETURNED PEN NEEDLES WERE EXAMINED AND THE FOLLOWING WAS OBSERVED: 5 SAFETY PEN NEEDLES EXHIBITED BOTH A BENT NON PATIENT END CANNULA AND ACTIVATED PATIENT END CANNULA SAFETY SHIELD. 1 SAFETY PEN NEEDLE EXHIBITED A BENT NON PATIENT END AND INACTIVATED PATIENT END CANNULA SAFETY SHIELD. 2 SAFETY PEN NEEDLES EXHIBITED FULLY ACTIVATED SAFETY SHIELDS ON BOTH THE PATIENT END AND NON-PATIENT END CANNULA SIDES. ALL RETURNED SAMPLES WERE TESTED FOR VISUAL INSPECTION OF POINT GEOMETRY. THE FOLLOWING WAS OBSERVED: DATA: POINT (PE/NPE) SAMPLE 1: GOOD/BENT, SAMPLE 2: GOOD/BENT, SAMPLE 3: GOOD/BENT, SAMPLE 4: GOOD/BENT, SAMPLE 5: GOOD/BENT, SAMPLE 6: GOOD/BENT, SAMPLE 7: GOOD/GOOD AND SAMPLE 8: GOOD/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 AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: -CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (BENT NON-PATIENT END CANNULA) - THE BENT NEEDLE ON THE NON-PATIENT END OF THE CANNULA WOULD BE THE CAUSE FOR NO MEDICATION FLOWING THROUGH, HENCE THE CUSTOMER WOULD THINK THE NEEDLE WAS CLOGGED (AS REPORTED). 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. ROOT CAUSE: THE POSSIBLE ROOT CAUSE FOR THIS ISSUE (BENT NON-PATIENT END CANNULA) IS: USER ERROR. NO EVIDENCE OF MANUFACTURING RELATED ISSUES WERE OBSERVED ON THE RETURNED SAMPLES. IT IS BD¿S EXPERIENCE THAT THE NON-PATIENT END BREAKAGE AND BENDING IS DIRECTLY ASSOCIATED WITH THE PLACING OF THE NEEDLE ONTO THE PEN DEVICE BY THE USER. IF THE NON-PATIENT END OF THE NEEDLE IS NOT PLACED CENTRALLY TO THE PEN DEVICE, THEN INSTEAD OF THE NON-PATIENT END OF THE NEEDLE PIERCING THE RUBBER SEPTUM OF THE VIAL, IT HITS HARD MATERIAL AND CAN BE BENT/BROKEN WHEN FITTED TO THE PEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE OF BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE WAS NOT PENETRATING SKIN. ALSO REPORTED PEN NEEDLE JAMMING, AND NO INSULIN FLOW DURING INJECTION. VERBATIM: FROM PHONE CALL ON (B)(6) 2019 13:33:05: LOT: 8170783, EXPIRATION DATE: 2021-07, OCCURRENCE DATE UNKNOWN. CONSUMER STATED HE DOES NOT PRIME BEFORE USE. STATED NOW INSULIN FLOW DURING INJECTION. NO INJURY TO REPORT. WALGREENS PHARMACY CALLED TO REPORT THAT A CONSUMER REMARKED TO HIM THAT HIS AUTOSHIELD DUO PEN NEEDLES WERE NOT PUNCTURING THE SKIN AS THEY SHOULD, GET JAMMED/MALFUNCTIONING. PHARMACIST STATED THAT CONSUMER WOULD LIKE A PHONE CALL TO EXPLAIN MORE. LOT NUMBER , SAMPLE RETURN, AND DATE OF OCCURRENCE WAS NOT PROVIDED TO CALLER BUT CONSUMER WILL PROBABLY KNOW.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE OF BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE WAS NOT PENETRATING SKIN. ALSO REPORTED PEN NEEDLE JAMMING, AND NO INSULIN FLOW DURING INJECTION. VERBATIM: FROM PHONE CALL ON (B)(6) 2019 13:33:05: LOT: 8170783, EXPIRATION DATE: 2021-07, OCCURRENCE DATE UNKNOWN. CONSUMER STATED HE DOES NOT PRIME BEFORE USE. STATED NOW INSULIN FLOW DURING INJECTION. NO INJURY TO REPORT. (B)(6) PHARMACY CALLED TO REPORT THAT A CONSUMER REMARKED TO HIM THAT HIS AUTOSHIELD DUO PEN NEEDLES WERE NOT PUNCTURING THE SKIN AS THEY SHOULD, GET JAMMED/MALFUNCTIONING. PHARMACIST STATED THAT CONSUMER WOULD LIKE A PHONE CALL TO EXPLAIN MORE. LOT NUMBER, SAMPLE RETURN, AND DATE OF OCCURRENCE WAS NOT PROVIDED TO CALLER BUT CONSUMER WILL PROBABLY KNOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234846 BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8170783 00382903295159

    Patients

    Seq Age Sex Outcome Treatment
    1 Other