BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 8465860 · Received March 29, 2019

    Report

    Report Number
    3002682307-2019-00210
    Event Type
    Malfunction
    Date Received
    March 29, 2019
    Date of Event
    November 30, 2018
    Report Date
    May 16, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT, CONSIDERING OUR IN-COMING AND IN-PROCESS INSPECTION. BD HAS NOT BEEN PROVIDED WITH PHOTOS OR SAMPLES FOR CATALOG 309050 LOT 1803102 TO INVESTIGATE FOR THIS RECORD. UNFORTUNATELY, AS A RESULT, BD WAS UNABLE TO VERIFY THE REPORTED ISSUE OR DETERMINE A DEFINITIVE ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE OF BD DISCARDIT¿ II SYRINGE WAS SEPARATED FROM SYRINGE DURING INTRA-MUSCULAR INJECTION OF 5 DOSES OF HALDOL DECANOS. CUSTOMER¿S VERBATIM: ¿ DURING AN INTRA-MUSCULAR INJECTION OF 5 DOSES OF HALDOL DECANOS, THE SYRINGE DISCONNECTED FROM THE NEEDLE. THE 5 ML SYRINGE CONTAINED 5 DOSES OF 1 ML OF HALDOL DECANOAS. THE SYRINGE AND THE NEEDLE, HOWEVER, SEEMED TO BE PROPERLY ATTACHED TO EACH OTHER. HALDOL IS KNOWN TO BE OILY AND PARTICULARLY DIFFICULT TO INJECT INTO MUSCLES, WITH THE RESISTANCE POTENTIALLY RESULTING IN DISCONNECTION. THE HCW RECEIVED HALDOL IN THE EYES AND ON THE FACE.¿

    Additional Manufacturer Narrative · 1

    (B)(6). 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 THE NEEDLE OF BD DISCARDIT¿ II SYRINGE WAS SEPARATED FROM SYRINGE DURING INTRA-MUSCULAR INJECTION OF 5 DOSES OF HALDOL DECANOS. CUSTOMER¿S VERBATIM: ¿DURING AN INTRA-MUSCULAR INJECTION OF 5 DOSES OF HALDOL DECANOS, THE SYRINGE DISCONNECTED FROM THE NEEDLE. THE 5 ML SYRINGE CONTAINED 5 DOSES OF 1 ML OF HALDOL DECANOAS. THE SYRINGE AND THE NEEDLE, HOWEVER, SEEMED TO BE PROPERLY ATTACHED TO EACH OTHER. HALDOL IS KNOWN TO BE OILY AND PARTICULARLY DIFFICULT TO INJECT INTO MUSCLES, WITH THE RESISTANCE POTENTIALLY RESULTING IN DISCONNECTION. THE HCW RECEIVED HALDOL IN THE EYES AND ON THE FACE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260302 BD DISCARDIT¿ II SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1803102

    Patients

    Seq Age Sex Outcome Treatment
    1 Other