BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE¿ NEEDLE

    MDR report key: 17796013 · Received September 21, 2023

    Report

    Report Number
    1213809-2023-01051
    Event Type
    Malfunction
    Date Received
    September 21, 2023
    Date of Event
    August 8, 2023
    Report Date
    September 25, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059165
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THE NEEDLES MALFUNCTIONED. TO AID IN THE INVESTIGATION, FIVE SAMPLES IN SEALED PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN CONNECTED TO A SYRINGE WITH SALINE SOLUTION. EACH NEEDLE EXPELLED THE SOLUTION WITH A NORMAL FLOW. A DEVICE HISTORY RECORD WAS REVIEWED FOR PROVIDED MATERIAL NUMBER 305916, LOT 2024138. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 2024138 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. ADDITIONAL DEVICE HISTORIES WERE REVIEWED FOR EACH BATCH OF NEEDLES USED IN THE MANUFACTURING OF THIS BATCH. THERE WAS NO DOCUMENTATION OF THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN OF THESE BATCH NUMBERS. PREVIOUS INVESTIGATIONS HAVE DETERMINED THAT PROCESS VARIATIONS DURING THE NEEDLE LUBRICANT APPLICATION CAN INDUCE CLOGGED NEEDLES. SEVERAL QUALITY INITIATIVES HAVE BEEN IMPLEMENTED IN THE MANUFACTURING PROCESS TO ENSURE THE NEEDLE LUBRICATION IS APPLIED APPROPRIATELY. ADDITIONALLY, A MONITORING PROGRAM IS ALSO IN PLACE TO VERIFY THE NEEDLE LUBRICANT IS APPLIED UNIFORMLY TO THE NEEDLE. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    NO ADDITIONAL INFORMATION RECEIVED. MATERIAL#: 305916, BATCH#:2024138. IT WAS REPORTED BY CUSTOMER THAT 3 LPNS BROUGHT SAFETY GLIDE NEEDLES THAT MALFUNCTIONED. TOTAL OF 7 NEEDLES. THEY STATED THAT THEY THEN TRIED ANOTHER NEEDLE (SAME LOT) AND THEY WORKED THIS WAS THE 25G X 1 INCH SAFETY GLIDE NEEDLE. VERBATIM: WE ARE REPORTING A FAILURE THAT OCCURRED FOR BD#305916 SAFETY GLIDE NEEDLE 25 GAUGE. BELOW IS THE DATE, LOCATION, MFR. ITEM# AND LOT # AFFECTED. THESE NEEDLES WERE PURCHASED BY XXX. I ALSO TRIED TO PROVIDE ANSWERS BELOW TO THE QUESTIONS YOU SEND TO US FOR EACH CASE WE REPORT, PLEASE SEE BELOW. PRODUCT DESCRIPTION : 25 GAUGE SAFETY GLIDE NEEDLE. DATE EVENT OCCURANCE: 8/8/2023. DEPT/LOCATION:XXX. LOT #: 2024138. BD MFR. ITEM #: 305916. LGH LAWSON #: 003592. DETAILED DESCRIPTION OF EVENT REPORTED: 3 LPNS BROUGHT SAFETY GLIDE NEEDLES THAT MALFUNCTIONED. TOTAL OF 7 NEEDLES. THEY STATED THAT THEY THEN TRIED ANOTHER NEEDLE (SAME LOT) AND THEY WORKED THIS WAS THE 25G X 1 INCH SAFETY GLIDE NEEDLE. ANY RETURN LABELS WOULD NEED TO BE SENT TO ATTN OF XXX. PLEASE SEND THE FEDEX LABEL TO XXX. IS THIS PRODUCT SHIPPED TO YOUR FROM A DISTRIBUTOR OR DIRECTLY FROM BD? (PLEASE SPECIFY) ITEM WAS PURCHASED FROM XXX. WHEN WAS THE ISSUE FIRST DETECTED? AUG 2023. WHEN THE PRODUCT WAS FIRST RECEIVED, WAS THERE ANY DETERIORATION ON THE PACKAGING? (ON THE OUTSIDE OF THE BOX OR ON THE FOILS?) NO. ARE THERE LOTS THAT PERFORMED SATISFACTORY IN THE PAST WITHOUT THIS ISSUE? YES. WHAT ARE THE PRODUCTS STORAGE CONDITIONS? BD NEEDLES ARE STOCKED IN OUR LGH STOREROOM, IN A TEMP CONTROLLED ENVIRONMENT, THEN ISSUED OUT BY COURIER TO AMBULATORY OUTPATIENT SITES. WHO COLLECTED THE SAMPLE (PHLEBOTOMIST, NURSE, ETC.)? XXX. HAS THE ISSUE PRESENTED ON MORE THAN ONE STAFF MEMBER? THREE LPN¿S REPORTED. QUANTITY OF PRODUCT RECEIVED? (FROM THE SAME LOT#) 7 EA TOTAL FROM SAME LOT #. QUANTITY OF PRODUCT AFFECTED? (PLEASE SPECIFY THE NUMBER OF INCIDENTS) 7 EA. IS THE LOT# AFFECTED STILL IN USE OR WAS IT REJECTED. IT IS STILL IN USE. HOW MANY SAMPLES PER DAY ARE PROCESSED? INPATIENT: ~800; OUTPATIENT: ~7-10K. PLEASE DESCRIBE THE TECHNIQUE THAT WAS USED TO DRAW BLOOD. WAS THERE BLOOD EXPOSURE? NO. IF YES, WHERE DID THE EXPOSURE OCCUR TO? (WAS IT THE EYE, MOUTH, OPEN CUT, ETC). WAS MEDICAL INTERVENTION REQUIRED OR NECESSARY? NO. ANY OTHER PATIENT IMPACT? NO. DID BLOOD NEEDED TO BE RECOLLECTED? NO. ANY OTHER PATIENT IMPACT: NO. WERE ANY ERRONEOUS RESULTS REPORTED TO HEALTHCARE PROVIDER? NO. ADDITIONAL INFO FROM CUSTOMER: (20-SEP-2023). SORRY FOR THE DELAY, THE PRACTICE MANAGER WHO PLACED THIS SAFETY ALERT IN OUR SYSTEM IS OUT ON MEDICAL LEAVE. ACCORDING TO THEIR NURSE SUPERVISOR, WHEN MEDICINE WAS DRAWN UP IN THE SYRINGE & NURSE WENT TO ADVANCE THE PLUNGER IT WOULD NOT ADVANCE. THE NEEDLE DID NOT BREAK. THE NUMBER OF OCCURRENCE REPORTED WAS 7 EA OF THAT BD#305916.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 7 BD SAFETYGLIDE¿ NEEDLES WERE BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE ARE REPORTING A FAILURE THAT OCCURRED FOR BD#305916 SAFETY GLIDE NEEDLE 25 GAUGE. DETAILED DESCRIPTION OF EVENT REPORTED: 3 LPNS BROUGHT SAFETY GLIDE NEEDLES THAT MALFUNCTIONED. TOTAL OF 7 NEEDLES. THEY STATED THAT THEY THEN TRIED ANOTHER NEEDLE (SAME LOT) AND THEY WORKED THIS WAS THE 25G X 1 INCH SAFETY GLIDE NEEDLE. WHEN WAS THE ISSUE FIRST DETECTED? (B)(6) 2023. WHEN THE PRODUCT WAS FIRST RECEIVED, WAS THERE ANY DETERIORATION ON THE PACKAGING? (ON THE OUTSIDE OF THE BOX OR ON THE FOILS?) NO. ARE THERE LOTS THAT PERFORMED SATISFACTORY IN THE PAST WITHOUT THIS ISSUE? YES. WHAT ARE THE PRODUCTS STORAGE CONDITIONS? BD NEEDLES ARE STOCKED IN OUR LGH STOREROOM, IN A TEMP CONTROLLED ENVIRONMENT, THEN ISSUED OUT BY COURIER TO AMBULATORY OUTPATIENT SITES. ARE THE TRANSFER DEVICES SEALED DURING STORAGE? N/A. WHO COLLECTED THE SAMPLE (PHLEBOTOMIST, NURSE, ETC.)? XXX. HAS THE ISSUE PRESENTED ON MORE THAN ONE STAFF MEMBER? THREE LPN¿S REPORTED. QUANTITY OF PRODUCT RECEIVED? (FROM THE SAME LOT#) 7 EA TOTAL FROM SAME LOT #. QUANTITY OF PRODUCT AFFECTED? (PLEASE SPECIFY THE NUMBER OF INCIDENTS) 7 EA. IS THE LOT# AFFECTED STILL IN USE OR WAS IT REJECTED. IT IS STILL IN USE. HOW MANY SAMPLES PER DAY ARE PROCESSED? INPATIENT: ~800; OUTPATIENT: ~7-10K. PLEASE DESCRIBE THE TECHNIQUE THAT WAS USED TO DRAW BLOOD: WAS THERE BLOOD EXPOSURE? NO. IF YES, WHERE DID THE EXPOSURE OCCUR TO? (WAS IT THE EYE, MOUTH, OPEN CUT, ETC) WAS MEDICAL INTERVENTION REQUIRED OR NECESSARY? NO. ANY OTHER PATIENT IMPACT? NO. DID BLOOD NEEDED TO BE RECOLLECTED? NO. ANY OTHER PATIENT IMPACT: NO. WERE ANY ERRONEOUS RESULTS REPORTED TO HEALTHCARE PROVIDER? NO. ADDITIONAL INFO FROM CUSTOMER: (20-SEP-2023). SORRY FOR THE DELAY, THE PRACTICE MANAGER WHO PLACED THIS SAFETY ALERT IN OUR SYSTEM IS OUT ON MEDICAL LEAVE. ACCORDING TO THEIR NURSE SUPERVISOR, WHEN MEDICINE WAS DRAWN UP IN THE SYRINGE & NURSE WENT TO ADVANCE THE PLUNGER IT WOULD NOT ADVANCE. THE NEEDLE DID NOT BREAK. THE NUMBER OF OCCURRENCE REPORTED WAS 7 EA OF THAT BD#305916."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712412 BD SAFETYGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 2024138 30382903059165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown