BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML S/T W/NDL 26X5/8 RB

    MDR report key: 9928844 · Received April 6, 2020

    Report

    Report Number
    1213809-2020-00237
    Event Type
    Malfunction
    Date Received
    April 6, 2020
    Date of Event
    March 15, 2020
    Report Date
    April 20, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095972
    PMA / PMN Number
    K980580
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED NO DEFECTS COULD BE CONFIRMED. THE ISSUE DESCRIBED IN THE COMPLAINT IS RELATED TO THE DESIGN OF THE PRODUCT ¿ SLIP TIP OR LUER SLIP. NO DEFECTS WITH THE DESIGN COULD BE CONFIRMED DUE TO NO SAMPLES BEING PROVIDED. THE SLIP TIP CONFIGURATION IS BY DESIGN AND IS NOT A DEFECT. AS A RESULT, A DEFINITIVE ROOT CAUSE COULD NOT BE DEFINED AND NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 1ML S/T W/NDL 26X5/8 RB NEEDLE COME OFF OF THE SYRINGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309597 BATCH NO.: 9076761, 9070752. IT WAS REPORTED IN THE INITIAL REPORT THAT THE NEEDLE COMES OFF OF THE SYRINGE WHEN DRAWING UP MEDICATION AS WELL AS DURING INJECTION. REPORTER REVIEWED THE RECORD AND STATED THE INCORRECT LOT NUMBERS WERE PROVIDED INITIALLY. VERBATIM: I WAS REVIEWING THIS RECORD AND REALIZED THE INCORRECT LOT NUMBERS WERE PROVIDED TO BD. CAREGIVER REPORTED IT IS THE DOSING SYRINGE THAT IS THE ISSUE. IT WAS REPORTED TO MEDICAL INFORMATION ON 04FEB2020 VIA PHONE CALL: RECEIVED A CALL FROM AN ONBOARD ACCESS SPECIALIST. THE CALLER STATED THAT A GATTEX PATIENT REPORTED WHEN PREPARING THE MEDICATION THE NEEDLE IS PUSHED ON THE SYRINGE AND THEN USED TO DRAW UP THE MEDICATION. WHEN DRAWING UP THE MEDICATION THE NEEDLE WILL COME OFF. THE CALLER STATED THE PATIENT ALSO REPORTED THAT WHEN THE NEEDLE IS INJECTED INTO THE SKIN IT WILL COME OFF. THE CALLER CONFIRMED THERE ARE NO MISSED DOSES. THE CALLER STATED THE PATIENT SUGGESTED THAT IT WOULD BE SO MUCH EASIER IF THE NEEDLE HAD A THREADED TIP INSTEAD OF A PUSH ON NEEDLE. THE PATIENT DOES NOT LIKE THE PUSH ON NEEDLES BUT WANTED TO SEE IF SOMEHOW IF THE TIP COULD COME WITH A SCREW ON TIP.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9076761. MEDICAL DEVICE EXPIRATION DATE: 2024-02-29. DEVICE MANUFACTURE DATE: 2019-03-17. MEDICAL DEVICE LOT #: 9070752. MEDICAL DEVICE EXPIRATION DATE: 2024-02-29. DEVICE MANUFACTURE DATE: 2019-03-11. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 1ML S/T W/NDL 26X5/8 RB NEEDLE COME OFF OF THE SYRINGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309597 BATCH NO.: 9076761, 9070752. IT WAS REPORTED IN THE INITIAL REPORT THAT THE NEEDLE COMES OFF OF THE SYRINGE WHEN DRAWING UP MEDICATION AS WELL AS DURING INJECTION. REPORTER REVIEWED THE RECORD AND STATED THE INCORRECT LOT NUMBERS WERE PROVIDED INITIALLY. VERBATIM: I WAS REVIEWING THIS RECORD AND REALIZED THE INCORRECT LOT NUMBERS WERE PROVIDED TO BD. CAREGIVER REPORTED IT IS THE DOSING SYRINGE THAT IS THE ISSUE. IT WAS REPORTED TO MEDICAL INFORMATION ON (B)(6) 2020 VIA PHONE CALL: RECEIVED A CALL FROM AN ONBOARD ACCESS SPECIALIST. THE CALLER STATED THAT A GATTEX PATIENT REPORTED WHEN PREPARING THE MEDICATION THE NEEDLE IS PUSHED ON THE SYRINGE AND THEN USED TO DRAW UP THE MEDICATION. WHEN DRAWING UP THE MEDICATION THE NEEDLE WILL COME OFF. THE CALLER STATED THE PATIENT ALSO REPORTED THAT WHEN THE NEEDLE IS INJECTED INTO THE SKIN IT WILL COME OFF. THE CALLER CONFIRMED THERE ARE NO MISSED DOSES. THE CALLER STATED THE PATIENT SUGGESTED THAT IT WOULD BE SO MUCH EASIER IF THE NEEDLE HAD A THREADED TIP INSTEAD OF A PUSH ON NEEDLE. THE PATIENT DOES NOT LIKE THE PUSH ON NEEDLES BUT WANTED TO SEE IF SOMEHOW IF THE TIP COULD COME WITH A SCREW ON TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392973 SYRINGE 1ML S/T W/NDL 26X5/8 RB PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309597 SEE H.10 30382903095972

    Patients

    Seq Age Sex Outcome Treatment
    1 Other