BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 RB

    MDR report key: 10690596 · Received October 16, 2020

    Report

    Report Number
    1213809-2020-00724
    Event Type
    Malfunction
    Date Received
    October 16, 2020
    Date of Event
    September 16, 2020
    Report Date
    October 19, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO CORRECTED INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: NO. D.10. RETURNED TO MANUFACTURER ON: NA. H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE 18X1-1/2 RB WAS CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLE HUB DEVELOPED A CRACK AND MEDICATION "SPRAYED" OUT THE SIDE OF THE NEEDLE. PER FOLLOW UP RESPONSE: FOR (B)(6): INCIDENT DATE? (B)(6) 2020. PHOTOS OF CRACKED HUB? PRODUCT WAS THROWN AWAY BEFORE PHOTOS COULD BE OBTAINED. CONFIRM NO INJURY TO PATIENT/STAFF- NO INJURY. IS DAMAGED ITEM AVAILABLE FOR RETURN INVESTIGATION? THIS SPECIFIC PRODUCT WAS THROWN AWAY BUT HAVE UNUSED PRODUCTS THAT CAN BE SENT. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: THERE HAD BEEN A FEW INSTANCES WHERE ONE OF MY CLINICS HAVE HAD ISSUES WITH A COUPLE BD PRODUCTS WHEN THEY WERE PERFORMING MEDICATION ADMINISTRATION. IN BOTH INSTANCES MEDICATION SPRAYED OUT OF THE NEEDLE/SYRINGE CONNECTION POINT. THE PRODUCTS THAT WERE USED, PRODUCT # AND LOT # ARE BELOW: BD 3ML SYRINGE WITH LUER-LOK TIP PRODUCT # 9870248 LOT # 0122550. BD PRECISION GLIDE NEEDLE 20G X 1¿ PRODUCT # 9872550 LOT # 8324804. PLEASE SEE THE 3 FORMS FOR MORE INFORMATION. ANY INFORMATION REGARDING WHETHER THIS IS A PRODUCT ISSUE OR USER ERROR WOULD BE APPRECIATED. EVENT DETAILS PER GLOBAL COMPLAINT FORMS STATES: IN SEPARATE INSTANCES, MY NURSING TEAM HAS HAD ISSUES WITH THE BD 3ML SYRINGE WHEN THEY WERE DRAWING UP OR ADMINISTERING MEDICATIONS. THE FIRST INSTANCE CAME ABOUT WHEN NURSING STAFF TIGHTENED A BD PRECISIONGLIDE 20G X 1" NEEDLE ONTO A BD 3ML SYRINGE TO DRAW UP MEDICATION TO ADMINISTER TO A PATIENT. WHEN THE NURSE PULLED THE PLUNGER BACK ON THE 3ML SYRINGE THE MEDICATION SPILLED OUT SURROUNDING THE NEEDLE/SYRINGE CONNECTION POINT."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE 18X1-1/2 RB WAS CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLE HUB DEVELOPED A CRACK AND MEDICATION "SPRAYED" OUT THE SIDE OF THE NEEDLE. PER FOLLOW UP RESPONSE: FOR 1835958 INCIDENT DATE? (B)(6) 2020 AND (B)(6) 2020 PHOTOS OF CRACKED HUB? PRODUCT WAS THROWN AWAY BEFORE PHOTOS COULD BE OBTAINED. CONFIRM NO INJURY TO PATIENT/STAFF- NO INJURY IS DAMAGED ITEM AVAILABLE FOR RETURN INVESTIGATION? THIS SPECIFIC PRODUCT WAS THROWN AWAY BUT HAVE UNUSED PRODUCTS THAT CAN BE SENT. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: THERE HAD BEEN A FEW INSTANCES WHERE ONE OF MY CLINICS HAVE HAD ISSUES WITH A COUPLE BD PRODUCTS WHEN THEY WERE PERFORMING MEDICATION ADMINISTRATION. IN BOTH INSTANCES MEDICATION SPRAYED OUT OF THE NEEDLE/SYRINGE CONNECTION POINT. THE PRODUCTS THAT WERE USED, PRODUCT # AND LOT # ARE BELOW: BD 3ML SYRINGE WITH LUER-LOK TIP PRODUCT # 9870248 LOT # 0122550 BD PRECISION GLIDE NEEDLE 20G X 1¿ PRODUCT # 9872550 LOT # 8324804 PLEASE SEE THE 3 FORMS FOR MORE INFORMATION. ANY INFORMATION REGARDING WHETHER THIS IS A PRODUCT ISSUE OR USER ERROR WOULD BE APPRECIATED. EVENT DETAILS PER GLOBAL COMPLAINT FORMS STATES: IN SEPARATE INSTANCES, MY NURSING TEAM HAS HAD ISSUES WITH THE BD 3ML SYRINGE WHEN THEY WERE DRAWING UP OR ADMINISTERING MEDICATIONS. THE FIRST INSTANCE CAME ABOUT WHEN NURSING STAFF TIGHTENED A BD PRECISIONGLIDE 20G X 1" NEEDLE ONTO A BD 3ML SYRINGE TO DRAW UP MEDICATION TO ADMINISTER TO A PATIENT. WHEN THE NURSE PULLED THE PLUNGER BACK ON THE 3ML SYRINGE THE MEDICATION SPILLED OUT SURROUNDING THE NEEDLE/SYRINGE CONNECTION POINT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1159109 NEEDLE 18X1-1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305916 8232563 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Other