BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS

    MDR report key: 11879235 · Received May 25, 2021

    Report

    Report Number
    2243072-2021-01529
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    April 26, 2021
    Report Date
    June 22, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SITE LEGAL NAME (FDA): HOLDREGE. B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS WAS UNABLE TO INJECT. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE CONSUMER HAD THREE NEEDLES WITH NO POINT ON THEM. ALSO, HAD DIFFICULTY GETTING THE NEEDLE IN THE VIAL AND CAN NOT INJECT INTO SITE. D.1. MEDICAL DEVICE BRAND NAME: SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS D.2. COMMON DEVICE NAME: PISTON SYRINGE D.3. MEDICAL DEVICE MANUFACTURER: HOLDREGE D.2. MEDICAL DEVICE CATALOG #: 328411 D.4. MEDICAL DEVICE EXPIRATION DATE: 2025-10-31, D.4. MEDICAL DEVICE LOT #: 0286561, D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.1. MANUFACTURING LOCATION: HOLDREGE. G.5. PMA/510(K)#: K170386. H.4. DEVICE MANUFACTURE DATE: 2020-10-12.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0286561. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE TWO (2) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS WAS UNABLE TO INJECT. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE CONSUMER HAD THREE NEEDLES WITH NO POINT ON THEM. ALSO, HAD DIFFICULTY GETTING THE NEEDLE IN THE VIAL AND CAN NOT INJECT INTO SITE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS WAS UNABLE TO INJECT. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE CONSUMER HAD THREE NEEDLES WITH NO POINT ON THEM. ALSO, HAD DIFFICULTY GETTING THE NEEDLE IN THE VIAL AND CAN NOT INJECT INTO SITE.DLE 29 GAUGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. INVESTIGATION CONCLUSION: 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. ROOT CAUSE DESCRIPTION: THE ROOT CAUSE IS UNDETERMINED. RATIONALE: BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNSPECIFIED BD¿ SYRINGE WAS UNABLE TO INJECT. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN BATCH NO: UNKNOWN IT WAS REPORTED THE CONSUMER HAD THREE NEEDLES WITH NO POINT ON THEM. ALSO, HAD DIFFICULTY GETTING THE NEEDLE IN THE VIAL AND CAN NOT INJECT INTO SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777975 SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0286561

    Patients

    Seq Age Sex Outcome Treatment
    1