BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500

    MDR report key: 9594346 · Received January 15, 2020

    Report

    Report Number
    1920898-2020-00008
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    December 31, 2019
    Report Date
    February 28, 2020
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908440035
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (20) LOOSE 3/10CC, 8MM, 31G SYRINGES. CUSTOMER STATES THAT THERE ARE PAINFUL INJECTIONS, IT¿S DIFFICULT TO PUSH THE NEEDLES INTO HER INJECTION SITE, SHE IS NOT SURE IF SHE GOT ALL HER INSULIN, AND THERE IS BRUISING. ALL RETURNED SYRINGES WERE TESTED POINT GEOMETRY, LUBE, AND CANNULA OD (SPECS: OUTER DIAMETER FOR 31G: 0.0100¿-0.0105¿). FIVE OUT OF 20 SAMPLES EXHIBITED A HOOKED CANNULA POINT. ALL SAMPLES WERE ALSO TESTED AND ALL WERE ABLE TO DRAW AND EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9161989. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE(HOOKED POINT). UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (DIFFICULT TO OPERATE). HOOKED POINT CAUSED BY CUSTOMER DURING USE OF THE PRODUCT. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF (B)(6) 2020 THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9161989. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES 0.3ML 31GA 8MM HALFUNIT 10BG 500 EXPERIENCED UNDER OR OVER DOSAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328440; BATCH NO: 9161989. VERBATIM: CONSUMER REPORTED PAINFUL INJECTIONS WITH THIS BATCH. STATED, ITS DIFFICULT TO PUSH THE NEEDLES INTO HER INJECTION SITE. STATED, SHE'S NOT GETTING A SMOOTH INJECTION LIKE SHE NORMALLY DOES. STATED, NOT SURE IF SHE GOT ALL HER INSULIN FROM SHOT THIS MORNING. STATED, WITH THE SHOT TODAY, SHE WAS NOT SURE IF SHE GOT ALL HER INSULIN, (THIS IS THE ONLY DAY SHE'S QUESTIONING IF SHE GOT COMPLETE DOSAGE) (B)(6) 2019. STATED, SHE'S USED TWO BAGS SO FAR FROM THIS BOX SHE'S REPORTING. STATED, USING BD PRODUCTS FOR DECADES AND NEVER HAD ISSUE. STATED, SHE DOES EXPERIENCE PAIN AND BRUISING WITH EVERY SHOT SO FAR FROM THIS BOX BUT IT GOES AWAY. HAS NOT SEEN A DOCTOR AND DOES NOT PLAN ON SEEING A DOCTOR. LOT: 9161989; ITEM: 328440; EXPIRATION DATE: 2024-06-30; SAMPLES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES 0.3ML 31GA 8MM HALFUNIT 10BG 500 EXPERIENCED UNDER OR OVER DOSAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328440 BATCH NO: 9161989 VERBATIM: CONSUMER REPORTED PAINFUL INJECTIONS WITH THIS BATCH STATED, ITS DIFFICULT TO PUSH THE NEEDLES INTO HER INJECTION SITE STATED, SHE'S NOT GETTING A SMOOTH INJECTION LIKE SHE NORMALLY DOES STATED, NOT SURE IF SHE GOT ALL HER INSULIN FROM SHOT THIS MORNING. STATED, WITH THE SHOT TODAY, SHE WAS NOT SURE IF SHE GOT ALL HER INSULIN, (THIS IS THE ONLY DAY SHE'S QUESTIONING IF SHE GOT COMPLETE DOSAGE) (B)(6) 2019 STATED, SHE'S USED TWO BAGS SO FAR FROM THIS BOX SHE'S REPORTING STATED, USING BD PRODUCTS FOR DECADES AND NEVER HAD ISSUE STATED, SHE DOES EXPERIENCE PAIN AND BRUISING WITH EVERY SHOT SO FAR FROM THIS BOX BUT IT GOES AWAY. HAS NOT SEEN A DOCTOR AND DOES NOT PLAN ON SEEING A DOCTOR. LOT: 9161989 ITEM: 328440 EXPIRATION DATE: 2024-06-30. SAMPLES AVAILABLE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES 0.3ML 31GA 8MM HALFUNIT 10BG 500 EXPERIENCED UNDER OR OVER DOSAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328440, BATCH NO: 9161989. VERBATIM: CONSUMER REPORTED PAINFUL INJECTIONS WITH THIS BATCH. STATED, ITS DIFFICULT TO PUSH THE NEEDLES INTO HER INJECTION SITE. STATED, SHE'S NOT GETTING A SMOOTH INJECTION LIKE SHE NORMALLY DOES. STATED, NOT SURE IF SHE GOT ALL HER INSULIN FROM SHOT THIS MORNING. STATED, WITH THE SHOT TODAY, SHE WAS NOT SURE IF SHE GOT ALL HER INSULIN, (THIS IS THE ONLY DAY SHE'S QUESTIONING IF SHE GOT COMPLETE DOSAGE) (B)(6) 2019. STATED, SHE'S USED TWO BAGS SO FAR FROM THIS BOX SHE'S REPORTING. STATED, USING BD PRODUCTS FOR DECADES AND NEVER HAD ISSUE. STATED, SHE DOES EXPERIENCE PAIN AND BRUISING WITH EVERY SHOT SO FAR FROM THIS BOX BUT IT GOES AWAY. HAS NOT SEEN A DOCTOR AND DOES NOT PLAN ON SEEING A DOCTOR. LOT: 9161989, ITEM: 328440, EXPIRATION DATE: 2024-06-30. SAMPLES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57319 SYRINGE 0.3ML 31GA 8MM HALFUNIT 10BG 500 PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328440 9161989 00382908440035

    Patients

    Seq Age Sex Outcome Treatment
    1 Other