BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE CATHETER TIP 2OZ

    MDR report key: 9324638 · Received November 14, 2019

    Report

    Report Number
    1911916-2019-01209
    Event Type
    Malfunction
    Date Received
    November 14, 2019
    Date of Event
    October 30, 2019
    Report Date
    December 11, 2019
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    KYZ
    UDI-DI
    30382903096207
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ELEVEN CUBES WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE RETURNED CUBES WERE VISUALLY EXAMINED USING UNAIDED VISION AND WERE ALL FOUND TO BE LABELED AS 50ML SYRINGE CATHETER TIP PRODUCT. THE CHANGE IN SCALE MARK FROM 60 ML TO 50 ML WAS AN INTENTIONAL CHANGE, AND NOT A NON-CONFORMANCE. BD HAS MADE A BUSINESS DECISION TO MOVE FROM 60 ML SYRINGES TO 50 ML SYRINGES BASED ON THE FOLLOWING REASONS: HELP DRIVE SAFE STERILE COMPOUNDING PRACTICE BY PREVENTING OVERFILL OF MEDICATIONS AND COMPLYING WITH ASEPTIC TECHNIQUE. STANDARDIZE THE BD® LARGE VOLUME SYRINGE OFFERING A BETTER MANAGE MARKET SUPPLY AND MITIGATE THE RISK OF PRODUCT SHORTAGES RESULTING FROM MARKET RELATED EVENTS. 3. ALIGN WITH OTHER MEDICATION RECEPTACLES THAT MAY BE IN SHORT SUPPLY (I.E. 50 ML MINI BAGS, 50% DEXTROSE PREFILLED SYRINGE, SODIUM BICARBONATE PREFILLED SYRINGE, ECT.) TO FACILITATE PRODUCT SUBSTITUTION WITH NO ANTICIPATED CLINICAL IMPACT. PRIOR TO CHANGING THE PRODUCT TO 50 ML, NOTIFICATIONS WERE SENT TO THE CUSTOMERS ABOUT THE UPCOMING CHANGE. THE LETTER, WHICH WAS DATED (B)(6) 2019, SPECIFIES THAT 50 ML SYRINGES COULD ARRIVE AT FACILITIES BETWEEN (B)(6) AND (B)(6) 2019. 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD¿ SYRINGE CATHETER TIP 2OZ HAS BEEN FOUND EXPERIENCING 11 OCCURRENCES OF MIXED PRODUCT/LOTS BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CUSTOMER HAD 11CASES OF PRODUCT AND WHILE PICKING ITEM 309620 LOT 9240840 WHICH IS LABELED AS A 50ML, THE PRODUCT WAS MIXED WITH ITEM NO 309620 LOT 9056659 WHICH IS LABELED AS A 60ML VERBATIM: CUSTOMER CALLED STATING THEY HAVE 11CASES OF PRODUCT AND WHILE PICKING ITEM 309620 LOT 9240840 WHICH IS LABELED AS A 50ML, THE PRODUCT WAS MIXED WITH ITEM NO 309620 LOT 9056659 WHICH IS LABELED AS A 60ML.

    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.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD¿ SYRINGE CATHETER TIP 2OZ HAS BEEN FOUND EXPERIENCING 11 OCCURRENCES OF MIXED PRODUCT/LOTS BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CUSTOMER HAD 11 CASES OF PRODUCT AND WHILE PICKING ITEM 309620 LOT 9240840 WHICH IS LABELED AS A 50ML, THE PRODUCT WAS MIXED WITH ITEM NO 309620 LOT 9056659 WHICH IS LABELED AS A 60ML. VERBATIM: CUSTOMER CALLED STATING THEY HAVE 11 CASES OF PRODUCT AND WHILE PICKING ITEM 309620 LOT 9240840 WHICH IS LABELED AS A 50ML, THE PRODUCT WAS MIXED WITH ITEM NO 309620 LOT 9056659 WHICH IS LABELED AS A 60ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114205 BD¿ SYRINGE CATHETER TIP 2OZ IRRIGATING SYRINGE KYZ BECTON DICKINSON AND COMPANY 9056659 30382903096207

    Patients

    Seq Age Sex Outcome Treatment
    1 Other