BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISIONGLIDE

    MDR report key: 24366904 · Received February 17, 2026

    Report

    Report Number
    1213809-2026-00068
    Event Type
    Malfunction
    Date Received
    February 17, 2026
    Date of Event
    October 7, 2025
    Report Date
    March 25, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096268
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4). SUPPLEMENTAL MDR - NEEDLE THROUGH SHIELD. SIX PHOTOS OF A 1ML LUER SLIP SYRINGE (PART NUMBER 309626), BATCH 4303406, WERE RECEIVED AND EVALUATED. THREE PHOTOS SHOW THE TOP WEB OF THE PACKAGE WITH APPLICABLE PRODUCT INFORMATION; HOWEVER, THE TIGHTNESS OF THE NEEDLE SHIELD CANNOT BE CONFIRMED. TWO PHOTOS SHOW A SYRINGE WITH A NEEDLE ATTACHED, WHERE THE NEEDLE IS BENT AND PROTRUDING THROUGH THE SIDE OF THE PLASTIC SHIELD, AND ONE PHOTO PROVIDES A CLOSE UP VIEW OF THE EXPOSED NEEDLE. THE REMAINING THREE PHOTOS SHOW THE PACKAGING TOP WEB. THE OBSERVED CONDITION IS NON CONFORMING TO PRODUCT SPECIFICATIONS. BASED ON THE INVESTIGATION AND PHOTO EVALUATION, THE CUSTOMER REPORTED ISSUE IS CONFIRMED; HOWEVER, THIS CONDITION OCCURRED FOLLOWING RECAPPING OF THE NEEDLE ASSEMBLY, WHICH IS CONSIDERED OFF LABEL USE, AS NEEDLE ASSEMBLIES ARE NOT INTENDED TO BE RECAPPED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR LOT NUMBERS 4303406 AND 5113384. THE REVIEW IDENTIFIED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE APPRECIATE YOU BRINGING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND THE REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED IN TREND REPORTS AND MONITORED MONTHLY, AND THE COLLECTED DATA WILL BE REGULARLY REVIEWED BY THE BUSINESS TEAM FOR IDENTIFICATION OF ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 1ML S/T W/NDL 25X5/8 RB NEEDLE WENT THROUGH SHIELD. RCC RECEIVED A COMPLAINT VIA EMAIL. I HAVE HAD 5 DEFECTIVE NEEDLES ITEM NUMBER: (D1)00382903096268 IN THE LAST FEW MONTHS. I HAVE THE LOT NUMBERS FOR THEM. THE FIRST THREE THE SHEATH OF THE NEEDLE WAS CRACKED AND WHEN I WAS PUTTING THE NEEDLE BACK INTO THE SHEATH, THE NEEDLE WENT THROUGH THE CRACK AND STABBED ME. THIS HAPPENED WITH THREE DIFFERENT NEEDLES. THESE CAME FROM (B)(6) 2029 F LOT: 4303406 REF: 309626. A FEW DAYS AGO, I HAD TWO NEEDLES WHERE THE SHEATH WAS STUCK ON. ONE I COULDN'T REMOVE THE SHEATH AT ALL. THE SECOND ONE I MANAGED TO GET THE SHEATH OFF, BUT IN THE PROCESS, THE NEEDLE BENT AND SCRATCHED ME. THESE CAME FROM (B)(6) 2030 R LOT: 5113384 REF: 309626. THE CRACKED SHEATHS ISSUE WAS ON (B)(6) 2025 AND THE STUCK SHEATHS ISSUE WAS (B)(6) 2026. MY THUMB GOT PRICKED FROM THE CRACKED SHEATHS. THE SIDE OF MY HAND GOT SCRATCHED FROM TRYING TO PULL OFF THE STUCK SHEATHS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153474 PRECISIONGLIDE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4303406 00382903096268

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other