BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE

    MDR report key: 10103089 · Received May 29, 2020

    Report

    Report Number
    1920898-2020-00586
    Event Type
    Malfunction
    Date Received
    May 29, 2020
    Date of Event
    May 14, 2020
    Report Date
    June 18, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908438032
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: 2020-06-08. 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_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLES BENT AND SHIELD DOES NOT DETACH AS INTENDED ON LOT # 9161986. UNABLE TO PERFORM COMPLAINT LOT HISTORY CHECK FOR NEEDLES BENT FOR UNKNOWN LOT NUMBER. INVESTIGATION SUMMARY: CUSTOMER RETURNED THREE (3) 31GX8MM, 0.3ML BD INSULIN SYRINGES FROM AN OPEN POLYBAG FROM LOT 9161986. CONSUMER REPORTED DIFFICULTY REMOVING NEEDLE SHIELD AND NEEDLE IS BENT. ALL THREE RETURNED SYRINGES WERE EXAMINED, THEN TESTED TO DETERMINE THE SHIELD REMOVAL FORCE (SPECS: SHIELD REMOVAL FORCE FOR 0.3 ML SYRINGE AFTER STERILIZATION IS 0.85 TO 5.95LBS) AND THE FOLLOWING WAS OBSERVED: SAMPLE NUMBER SHIELD REMOVAL FORCE (LBS) SAMPLE 1; 2.43. SAMPLE 2; 3.77. SAMPLE 3; 3.58. ALL THREE SYRINGES TESTED WITHIN SPECIFICATION. IT WAS OBSERVED THAT TWO OUT OF THE THREE SYRINGES EXHIBITED BENT CANNULA. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED ON THE RETURNED SAMPLES. SINCE ALL THREE SYRINGES WERE RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE PROBABLE CAUSE OF THE BENT CANNULAS IS USER ERROR WHEN USING THE SYRINGES. IF THE USER REMOVES THE CANNULA SHIELD OBLIQUELY THEY MAY BEND THE CANNULA. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9161986. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS [200829078, 200828969, 200825252] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. INVESTIGATION CONCLUSION: 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 CANNULA) - UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (SHIELD DOES NOT DETACH AS INTENDED) 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: THE POSSIBLE ROOT CAUSE FOR THIS ISSUE (BENT CANNULA) IS: USER ERROR. NO EVIDENCE OF MANUFACTURING RELATED ISSUES WERE OBSERVED ON THE RETURNED SAMPLES. SINCE ALL THREE SYRINGES WERE RETURNED AFTER USE, THE PROBABLE CAUSE OF THE BENT CANNULAS IS USER ERROR WHEN USING THE SYRINGES. IF THE USER REMOVES THE CANNULA SHIELD OBLIQUELY THEY MAY BEND THE CANNULA. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE WAS BENT AND WAS NOT DRAWING INSULIN. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328438 BATCH NO: 9161986, UNKNOWN CONSUMER STATED DIFFICULTY REMOVING NEEDLE SHIELD, NEEDLE NOT DRAWING INSULIN AND NEEDLE IS BENT.

    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 #: 9161986, MEDICAL DEVICE EXPIRATION DATE: 2024-06-30, DEVICE MANUFACTURE DATE: 2019-06-10. MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: LEVEL A INVESTIGATION: COMPLAINT EVALUATION / COMPLAINT HISTORY CHECK FOR THE EVENT(S) THAT OCCURRED. SEVERITY: S_1__; OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT FOR NEEDLES BENT AND SHIELD DOES NOT DETACH AS INTENDED ON LOT # 9161986. UNABLE TO PERFORM COMPLAINT LOT HISTORY CHECK FOR NEEDLES BENT FOR UNKNOWN LOT NUMBER. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. 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# 9161986. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE THREE (3) NOTIFICATIONS [(B)(4)] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. INVESTIGATION CONCLUSION: AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE WAS BENT AND WAS NOT DRAWING INSULIN. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328438, BATCH NO: 9161986, UNKNOWN. CONSUMER STATED DIFFICULTY REMOVING NEEDLE SHIELD, NEEDLE NOT DRAWING INSULIN AND NEEDLE IS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563566 BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328438 SEE H.10 00382908438032

    Patients

    Seq Age Sex Outcome Treatment
    1 Other