BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ PEN NEEDLES

    MDR report key: 10002800 · Received April 27, 2020

    Report

    Report Number
    9616656-2020-00363
    Event Type
    Malfunction
    Date Received
    April 27, 2020
    Date of Event
    April 6, 2020
    Report Date
    June 2, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201228
    PMA / PMN Number
    K162516
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 7 MAY 2020 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. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. INVESTIGATION CONCLUSION: 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.

    Additional Manufacturer Narrative · 0

    HE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2020-05-13 H.6. INVESTIGATION SUMMARY THE CUSTOMER RETURNED FIVE (5) SEALED/UNUSED 32GX4MM BD PEN NEEDLES (TWO FROM LOT 1242474 AND THREE FROM 3073115). CONSUMER REPORTED THERE WAS NO INSULIN FLOW DURING INJECTION, THERE IS NO EXPIRATION DATE ON THE BOXES, AND AFTER THE LOT NUMBERS WERE PROVIDED, IT WAS NOTED, THE PRODUCT HAD EXPIRED. ALL FIVE RETURNED PEN NEEDLES WERE EXAMINED, THEN TESTED FOR FLOW USING A TEST PEN INJECTOR: ALL FIVE PEN NEEDLES WERE ABLE TO EXPEL PROPERLY. LOTS 1242474 AND 3073115 WERE MANUFACTURED ON OCTOBER 2011 AND MAY 2013, RESPECTIVELY, HOWEVER, NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED ON THE SAMPLES RECEIVED. SINCE NO DEFECTS WERE OBSERVED THE ALLEGED ISSUES COULD NOT BE CONFIRMED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BASED ON THE SAMPLES RECEIVED THE INVESTIGATION CONCLUDED 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 BD ULTRA FINE¿ PEN NEEDLES HAD NO INSULIN FLOW DURING INJECTION AND WAS USED AFTER THE PRODUCT HAD EXPIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 320122 BATCH NO.: 1242474, 3073115. IT WAS REPORTED THERE WAS NO INSULIN FLOW DURING INJECTION, THERE IS NO EXPIRATION DATE ON THE BOXES AND AFTER THE LOT NUMBERS WERE PROVIDED, IT WAS NOTED, THE PRODUCT HAD EXPIRED. VERBATIM: CONSUMER WAS ON THE LINE WITH PHARMACIST AND REPORTED PEN NEEDLES ARE NOT WORKING PROPERLY DURING INJECTIONS. STATED NO INSULIN FLOW DURING INJECTION. STATED TODAY SHE WENT THROUGH 7 PEN NEEDLES BEFORE RECEIVING HER MEDICATION. STATED OVERALL ABOUT 20-25 PEN NEEDLES (COMBINED FROM BOTH BOXES) DID NOT RELEASE INSULIN. STATED THERE IS NO EXPIRATION DATE ON THE BOXES. AFTER CONSUMER REPORTED LOT #'S ADVISED THAT THE PRODUCTS ARE EXPIRED. CONSUMER STATED SHE DID NOT KNOW BOTH BOXES HAD EXPIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ULTRA FINE¿ PEN NEEDLES HAD NO INSULIN FLOW DURING INJECTION AND WAS USED AFTER THE PRODUCT HAD EXPIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 320122 BATCH NO.: 1242474, 3073115. IT WAS REPORTED THERE WAS NO INSULIN FLOW DURING INJECTION, THERE IS NO EXPIRATION DATE ON THE BOXES AND AFTER THE LOT NUMBERS WERE PROVIDED, IT WAS NOTED, THE PRODUCT HAD EXPIRED. VERBATIM: CONSUMER WAS ON THE LINE WITH PHARMACIST AND REPORTED PEN NEEDLES ARE NOT WORKING PROPERLY DURING INJECTIONS. STATED NO INSULIN FLOW DURING INJECTION. STATED TODAY SHE WENT THROUGH 7 PEN NEEDLES BEFORE RECEIVING HER MEDICATION. STATED OVERALL ABOUT 20-25 PEN NEEDLES (COMBINED FROM BOTH BOXES) DID NOT RELEASE INSULIN. STATED THERE IS NO EXPIRATION DATE ON THE BOXES. AFTER CONSUMER REPORTED LOT #'S ADVISED THAT THE PRODUCTS ARE EXPIRED. CONSUMER STATED SHE DID NOT KNOW BOTH BOXES HAD EXPIRED.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1242474. MEDICAL DEVICE EXPIRATION DATE: N/A. DEVICE MANUFACTURE DATE: 2011-10-25. MEDICAL DEVICE LOT #: 3073115. MEDICAL DEVICE EXPIRATION DATE: N/A. DEVICE MANUFACTURE DATE: 2013-05-07. 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¿ PEN NEEDLES HAD NO INSULIN FLOW DURING INJECTION AND WAS USED AFTER THE PRODUCT HAD EXPIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 320122 BATCH NO.: 1242474, 3073115. IT WAS REPORTED THERE WAS NO INSULIN FLOW DURING INJECTION, THERE IS NO EXPIRATION DATE ON THE BOXES AND AFTER THE LOT NUMBERS WERE PROVIDED, IT WAS NOTED, THE PRODUCT HAD EXPIRED. VERBATIM: CONSUMER WAS ON THE LINE WITH PHARMACIST AND REPORTED PEN NEEDLES ARE NOT WORKING PROPERLY DURING INJECTIONS. STATED NO INSULIN FLOW DURING INJECTION. STATED TODAY SHE WENT THROUGH 7 PEN NEEDLES BEFORE RECEIVING HER MEDICATION. STATED OVERALL ABOUT 20-25 PEN NEEDLES (COMBINED FROM BOTH BOXES) DID NOT RELEASE INSULIN. STATED THERE IS NO EXPIRATION DATE ON THE BOXES. AFTER CONSUMER REPORTED LOT #'S ADVISED THAT THE PRODUCTS ARE EXPIRED. CONSUMER STATED SHE DID NOT KNOW BOTH BOXES HAD EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467286 BD ULTRA FINE¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320122 SEE H.10 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1 Other