BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HENRY SCHEIN INT. SHORT 30GA NEEDLE

    MDR report key: 3799231 · Received April 16, 2014

    Report

    Report Number
    2529586-2014-00001
    Event Type
    Injury
    Date Received
    April 16, 2014
    Report Date
    April 14, 2014
    Manufacturer
    S.O.F.I.C., S.A.
    Product Code
    DZM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS REPORT, LOCAL REFERENCE # (B)(4). INITIAL INFO RECEIVED THROUGH FDA'S MEDWATCH PROGRAM (B)(4)) DATED ON (B)(4) 2014 AND RECEIVED BY NOVOCOL ON (B)(6) 2014. THE DENTIST REPORTED THAT A PT (UNSPECIFIED GENDER), WITH NO SPECIFIED MEDICAL HISTORY HAD BEEN TREATED WITH HSI DISPOSABLE SHORT NEEDLE (HENRY SCHEIN INT. SHORT 30GA NEEDLE (BATCH NUMBER: F01214AA, EXPIRY DATE: FEBRUARY 2018). ON UNSPECIFIED DATE, PT WAS HOSPITALIZED AFTER THE NEEDLE AND SYRINGE BROKE DURING INJECTION. AT THE TIME OF THE REPORT, THE PT'S OUTCOME WAS UNK. NO MORE INFO WAS AVAILABLE. MEDICAL REVIEW ON (B)(6) 2014: A. SERIOUSNESS: SERIOUS DUE TO HOSPITALIZATION. B. EXPECTEDNESS: UNEXPECTED USA. C. CAUSALITY: A) LATENCY - POSSIBLE, B) RECOGNIZED ASSOCIATION - NO. C) ALTERNATIVE ETIOLOGY - THIS IS AN INCIDENT IN WHICH DURING THE ANESTHESIA PROCEDURE, THE NEEDLE BROKE. QC RESULT: NO DEFECT WAS DETECTED ON THE NEEDLES FROM THIS BATCH. OTHER ETIOLOGIES: STRESS DURING INTERVENTION OR INVOLUNTARY MOVEMENT OF THE PT COULD BE POSSIBLE CAUSES. INCIDENT ASSESSED NOT RELATED. D) DECHALLENGE - NA. E) RECHALLENGE - NA. CONCLUDED CAUSALITY: NOT RELATED. REF MFR # 3002987325-2014-00001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231692 HENRY SCHEIN INT. SHORT 30GA NEEDLE DENTAL NEEDLE DZM S.O.F.I.C., S.A. F01214AA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization