BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE II INSULIN SYRINGE

    MDR report key: 9931084 · Received April 6, 2020

    Report

    Report Number
    1920898-2020-00349
    Event Type
    Malfunction
    Date Received
    April 6, 2020
    Date of Event
    March 19, 2020
    Report Date
    July 30, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908325011
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL? YES. D.10. RETURNED TO MANUFACTURER ON: 2020-07-30. H.3. DEVICE RETURNED TO MANUFACTURER: YES. H.3. DEVICE EVAL BY MANUFACTURER: YES. H.6. INVESTIGATION SUMMARY: LEVEL A INVESTIGATION. COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_2__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR EXPIRED PRODUCT, CANNULA SEPARATES IN VIAL AND BREAKS OFF DURING USE (IN LEG) ON LOT # 3113039. INVESTIGATION SUMMARY: CUSTOMER RETURNED ONE (1) USED 0.5ML BD INSULIN SYRINGE IN AN OPEN POLYBAG FROM LOT 3113039. CUSTOMER REPORTED THAT WHEN INSULIN IS REMOVED THE METAL PART OF THE SYRINGE COMES OUT, IT HAPPENED THAT THE NEEDLE GOT STUCK IN HIS LEG. CUSTOMER ALSO REPORTED A NEEDLE IS COMPLETELY DETACHED FROM THE SYRINGE; HE REPORTED THAT IT GOT STUCK IN THE RUBBER OF THE VIAL. THE RETURNED SYRINGE WAS EXAMINED, AND IT WAS OBSERVED THAT THE CANNULA WAS SEPARATED FROM THE NEEDLE HUB. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED, HOWEVER, AS THE SAMPLE RETURNED WAS FROM AN EXPIRED LOT. AS PER MANUFACTURING: THIS PRODUCT EXPIRED ON 2018-04. AS PER THE INFORMATION IN THE PRODUCT GRID AND POLYBAG, THIS PRODUCT WAS MANUFACTURED IN APRIL 2013 AND EXPIRED IN APRIL 2018 -- THIS FALLS WITHIN SPECIFICATION REGARDING SHELF LIFE OF THE PRODUCT. AFTER THE EXPIRATION DATE OF APRIL 2018, THE SAMPLES SHOULD NOT BE USED AND SHOULD BE DISCARDED. SINCE NO DEFECTS WERE OBSERVED, THE ALLEGED ISSUES COULD NOT BE CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 3113039. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. THIS PRODUCT EXPIRED ON 2018-04. INVESTIGATION CONCLUSION: BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE SINCE THE PRODUCT RETURNED IS EXPIRED. 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. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BREAKAGE OCCURRED DURING USE WITH A BD ULTRA-FINE¿ II INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PATIENT INFORMED US THAT HE MAKES USE OF BD ULTRA-FINE 8MM SYRINGES IN 50UI CAPACITY, HOWEVER THE LOT WAS EXPIRED. WE ADVISE HIM TO NOT USE BD ULTRA-FINE PRODUCTS THAT ARE ALREADY EXPIRED. HE REPORTED THAT THE NEEDLE IS COMPLETELY DETACHED FROM THE SYRINGE. HE REPORTED THAT IT GOT STUCK IN THE RUBBER OF THE VIAL, AS SOON AS HE ASPIRATED THE INSULIN. WHEN THE NEEDLE GOT STUCK IN HIS LEG, HE SAID HE WAS ABLE TO REMOVE IT MANUALLY. THERE WAS NO BRUISING AND THE SITE WAS NOT PAINFUL."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER LAST NAME: (B)(6). INITIAL REPORTER PHONE#: (B)(6). INVESTIGATION SUMMARY: O SAMPLES WERE RETURNED 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 REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 3113039. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. THIS PRODUCT EXPIRED ON 2018-04. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BREAKAGE OCCURRED DURING USE WITH A BD ULTRA-FINE¿ II INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PATIENT INFORMED US THAT HE MAKES USE OF BD ULTRA-FINE 8MM SYRINGES IN 50UI CAPACITY, HOWEVER THE LOT WAS EXPIRED. WE ADVISE HIM TO NOT USE BD ULTRA-FINE PRODUCTS THAT ARE ALREADY EXPIRED. HE REPORTED THAT THE NEEDLE IS COMPLETELY DETACHED FROM THE SYRINGE. HE REPORTED THAT IT GOT STUCK IN THE RUBBER OF THE VIAL, AS SOON AS HE ASPIRATED THE INSULIN. WHEN THE NEEDLE GOT STUCK IN HIS LEG, HE SAID HE WAS ABLE TO REMOVE IT MANUALLY. THERE WAS NO BRUISING AND THE SITE WAS NOT PAINFUL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393026 BD ULTRA-FINE II INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 3113039 00382908325011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other