BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SOLOMED¿ 3ML SYRINGE

    MDR report key: 17592257 · Received August 21, 2023

    Report

    Report Number
    2243072-2023-01481
    Event Type
    Malfunction
    Date Received
    August 21, 2023
    Date of Event
    August 8, 2023
    Report Date
    October 31, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLES AND PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL EVALUATION, THE SAMPLE RECEIVED WAS OPENED IN A WAY THAT COULD COMPROMISE THE USE OF THE SYRINGE CAUSING DIFFICULT PLUNGER MOVEMENT. 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. TO OPEN THE BLISTER, THE SAMPLE IS TAKEN BY THE ¿PEEL APART " AND PAPER SHOULD BE HELD WITH ONE HAND, HOLDING IT WITH BOTH HANDS, BY THE INDEX FINGERS AND THUMB. AFTER HOLDING THE PACKAGING, OPEN THE BLISTER BY PULLING THE PACKAGING IN OPPOSITE DIRECTIONS. THE PAPER AND FILM IN THE PACKAGING MUST NOT BE BE COMPLETELY SEPARATED. THE BLISTER MUST BE OPENED IN A SINGLE MOVEMENT, WITH MODERATE SPEED, AND EQUAL FORCE IN BOTH HANDS. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. IT IS IMPORTANT TO FOLLOW INSTRUCTION FOR USE FOR THIS PRODUCT.

    Additional Manufacturer Narrative · 0

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND/OR LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H.4. DEVICE MANUFACTURE DATE: UNKNOWN H3. 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

    ADDITIONAL INFORMATION RECEIVED. WE'VE RECEIVED ONE MORE COMPLAINT IN WHICH THE USER REPORTS DIFFICULT WITH THE PLUNGER WHILE HANDLING THE MEDICATION, THIS COMPLAINT IS ASSOCIATED TO THE SAME ISSUE OF THE PREVIOUS PR# (B)(4). THE BATCHES ARE POTENTIAL LOT NUMBERS. CUSTOMER PROVIDED TO US THE ADDITIONAL INFORMATION BELOW. (F. FENERICH 25.AUG.2023) -MATERIAL AND BATCH #S; THE BATCH OF MATERIAL 2073245, 2073242 AND 2077110 . I DON'T HAVE INFORMATION ABOUT THE CATALOGUE. WAS THERE ANY CLINICAL IMPACT TO PATIENT OR WAS MEDICAL INTERVENTION NEEDED? IN ALL CASES, THE MEDICATION WAS REPLACED FOR THE CLIENT. IS IT THE SAME MEDICATION OF PR# (B)(4). (BETATRINTA)? YES, ALL COMPLAINTS ARE ABOUT BETATRINTA. PLEASE DESCRIBE THE ISSUE IN DETAILS: THE PLUNGER GOT LOOSE FROM THE SYRINGE, NOT BEING ABLE TO ASPIRATE THE MEDICINE. WAS ANY PHYSICAL DAMAGE NOTED? DOES THE PLUNGER ROD REACH THE END OF BARREL, IS BARREL CRACKED, IS STOPPER WELL POSITIONED, ETC.? PLEASE DESCRIBE: THE CUSTOMER DID NOT POINT OUT ANY OF THESE DETAILS. PLEASE PROVIDE PICTURES/VIDEOS. ATTACHED ARE THE PHOTOS. 24.OCT.23: ADD INFO RECEIVED. WHAT IS THE CORRECT BATCH AFFECTED? ARE THE BATCHES OF PR# 8662352 WRONG? YES, THEY ARE INCORRECT. SHALL BATCHES BE CHANGED FROM 2073245, 2073242 & 2077110 TO 2139737, 2202325 & 2202327? YES, FOR RM1530944 (8662352) REPLACE WITH 2139737, 2202325 AND 2202327 (CORRECT BATCHES) OR IS THERE A NEW COMPLAINT TO BATCHES 2139737, 2202325 & 2202327? NOT NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SOLOMED¿ 3ML SYRINGE THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: WE'VE RECEIVED ONE MORE COMPLAINT IN WHICH THE USER REPORTS DIFFICULT WITH THE PLUNGER WHILE HANDLING THE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2168157 BD SOLOMED¿ 3ML SYRINGE PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown