BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE 1.0ML 31G 6MM S/C U-100 RELION

    MDR report key: 11619049 · Received April 6, 2021

    Report

    Report Number
    1920898-2021-00381
    Event Type
    Injury
    Date Received
    April 6, 2021
    Date of Event
    March 16, 2021
    Report Date
    May 19, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131138345
    PMA / PMN Number
    K170386
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD WAS UPDATED DUE TO CORRECTED INFORMATION: H.1. TYPE OF REPORTABLE EVENTS: SERIOUS INJURY. H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9210965. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD WAS UPDATED DUE TO CORRECTED INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT SYRINGE 1.0ML 31G 6MM S/C U-100 RELION NEEDLE PIECED SHIELD AND CAUSED A NEEDLE STICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328519 BATCH NO. 9210965. IT WAS REPORTED THAT NEEDLE WAS THROUGH THE WALL AND STUCK HIMSELF WITH THE NEEDLE. FINGER WAS VERY BRUISED AND WAS TESTED FOR AIDS. VERBATIM: CONSUMER REPORTED NEEDLE STUCK ON THE SIDE OF BARREL OF SYRINGE. STUCK THIS CONSUMER WHEN HE GRABBED THE PACKET. WENT TO THE DOCTOR. HIS DOCTOR COMPLETED BLOOD WORK ON HIM FOR AIDS TWICE. SAID THE FINGER LOOKED BRUISED. THIS COMPLAINT WAS RECEIVED BY EMAIL ON 3-16-2020 AS SPAM AND NOT PROCESSED CORRECTLY ON CS0024318 CUSTOMER STATED HE PURCHASED THE RELION SYRINGES 6MM 1CC AND ONE OF THE SYRINGES HAS A NEEDLE INBREED INSIDE THE WALL ITSELF THE INSIDE THE WALL AND IT STUCK HIM ON THE JOINT OF HIS FINGER AND HE WENT TO THE DOCTOR THIS MORNING. CUSTOMER SAID THEY RAN SOME TEST ON HIM AND HE IS WAITING FOR HIS RESULTS. THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 4/30/2021. H.6. INVESTIGATION: CUSTOMER RETURNED (1) 31GX6MM, 1ML INSULIN SYRINGE WITH AN OPENED POLYBAG FROM LOT# 9210965. IT WAS REPORTED THAT NEEDLE STUCK ON THE SIDE OF BARREL OF SYRINGE, STUCK THIS CONSUMER WHEN HE GRABBED THE PACKET, AND FINGER LOOKED BRUISED. THE RETURNED SYRINGE WAS EXAMINED, AND IT WAS OBSERVED THAT A SINGLE CANNULA WAS ADHERED TO THE SYRINGE BARREL BETWEEN THE 30 AND 40 UNIT SCALE MARKING. THE EXPOSED CANNULA ADHERED TO THE BARREL COULD HAVE LED TO A NEEDLE STICK, AND POTENTIALLY CAUSED HARM/BRUISING. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9210965. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 1.0ML 31G 6MM S/C U-100 RELION NEEDLE PIECED SHIELD AND CAUSED A NEEDLE STICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328519, BATCH NO. 9210965. IT WAS REPORTED THAT NEEDLE WAS THROUGH THE WALL AND STUCK HIMSELF WITH THE NEEDLE. FINGER WAS VERY BRUISED AND WAS TESTED FOR AIDS. VERBATIM: CONSUMER REPORTED NEEDLE STUCK ON THE SIDE OF BARREL OF SYRINGE. STUCK THIS CONSUMER WHEN HE GRABBED THE PACKET. WENT TO THE DOCTOR. HIS DOCTOR COMPLETED BLOOD WORK ON HIM FOR AIDS TWICE. SAID THE FINGER LOOKED BRUISED. THIS COMPLAINT WAS RECEIVED BY EMAIL ON (B)(6) 2020 AS SPAM AND NOT PROCESSED CORRECTLY ON CS0024318. CUSTOMER STATED HE PURCHASED THE RELION SYRINGES 6MM 1CC AND ONE OF THE SYRINGES HAS A NEEDLE INBREED INSIDE THE WALL ITSELF THE INSIDE THE WALL AND IT STUCK HIM ON THE JOINT OF HIS FINGER AND HE WENT TO THE DOCTOR THIS MORNING. CUSTOMER SAID THEY RAN SOME TEST ON HIM AND HE IS WAITING FOR HIS RESULTS. INFORMED THE CUSTOMER TO PLEASE HOLD ONTO THE PRODUCT FOR POSSIBLE RETRIEVAL BY THE SUPPLIER. ISSUED $15 GIFT CARD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 1.0ML 31G 6MM S/C U-100 RELION NEEDLE PIECED SHIELD AND CAUSED A NEEDLE STICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328519 BATCH NO. 9210965. IT WAS REPORTED THAT NEEDLE WAS THROUGH THE WALL AND STUCK HIMSELF WITH THE NEEDLE. FINGER WAS VERY BRUISED AND WAS TESTED FOR AIDS. VERBATIM: CONSUMER REPORTED NEEDLE STUCK ON THE SIDE OF BARREL OF SYRINGE. STUCK THIS CONSUMER WHEN HE GRABBED THE PACKET. WENT TO THE DOCTOR. HIS DOCTOR COMPLETED BLOOD WORK ON HIM FOR AIDS TWICE. SAID THE FINGER LOOKED BRUISED. THIS COMPLAINT WAS RECEIVED BY EMAIL ON 3-16-2020 AS SPAM AND NOT PROCESSED CORRECTLY ON CS0024318 CUSTOMER STATED HE PURCHASED THE RELION SYRINGES 6MM 1CC AND ONE OF THE SYRINGES HAS A NEEDLE INBREED INSIDE THE WALL ITSELF THE INSIDE THE WALL AND IT STUCK HIM ON THE JOINT OF HIS FINGER AND HE WENT TO THE DOCTOR THIS MORNING. CUSTOMER SAID THEY RAN SOME TEST ON HIM AND HE IS WAITING FOR HIS RESULTS.

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: UNKNOWN. THE PATIENT¿S AGE WAS USED TO DETERMINE A PLACEHOLDER DATE. MEDICAL DEVICE EXPIRATION DATE: NA. 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 SYRINGE 1.0ML 31G 6MM S/C U-100 RELION NEEDLE PIECED SHIELD AND CAUSED A NEEDLE STICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328519 BATCH NO. 9210965. IT WAS REPORTED THAT NEEDLE WAS THROUGH THE WALL AND STUCK HIMSELF WITH THE NEEDLE. FINGER WAS VERY BRUISED AND WAS TESTED FOR (B)(6). VERBATIM: CONSUMER REPORTED NEEDLE STUCK ON THE SIDE OF BARREL OF SYRINGE. STUCK THIS CONSUMER WHEN HE GRABBED THE PACKET. WENT TO THE DOCTOR. HIS DOCTOR COMPLETED BLOOD WORK ON HIM FOR (B)(6) TWICE. SAID THE FINGER LOOKED BRUISED. THIS COMPLAINT WAS RECEIVED BY EMAIL ON 3-16-2020 AS SPAM AND NOT PROCESSED CORRECTLY ON (B)(4). CUSTOMER STATED HE PURCHASED THE RELION SYRINGES 6MM 1CC AND ONE OF THE SYRINGES HAS A NEEDLE INBREED INSIDE THE WALL ITSELF THE INSIDE THE WALL AND IT STUCK HIM ON THE JOINT OF HIS FINGER AND HE WENT TO THE DOCTOR THIS MORNING. CUSTOMER SAID THEY RAN SOME TEST ON HIM AND HE IS WAITING FOR HIS RESULTS. INFORMED THE CUSTOMER TO PLEASE HOLD ONTO THE PRODUCT FOR POSSIBLE RETRIEVAL BY THE SUPPLIER. ISSUED (B)(6) GIFT CARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522682 SYRINGE 1.0ML 31G 6MM S/C U-100 RELION PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328519 9210965 00681131138345

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention