BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WHITACRE SET 25GA 3.50 IN FOR INDIA

    MDR report key: 11276487 · Received February 3, 2021

    Report

    Report Number
    3003152976-2021-00062
    Event Type
    Malfunction
    Date Received
    February 3, 2021
    Date of Event
    January 11, 2021
    Report Date
    February 19, 2021
    Product Code
    CAZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY MULTIPLE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PICTURES RECEIVED DISPLAYS PACKAGES THAT ARE LABELED AS LOT 1901013, ITEM 405129 HOWEVER THE CONTENT CORRESPONDS TO PRODUCT FROM LOT 1906017, ITEM 405120. BASED ON THE PHOTO, WE ARE ABLE TO VERIFY THE REPORTED FAILURE. RETAINED SAMPLES OF EACH ITEM AND LOT NUMBER WERE INSPECTED AND ALL PRODUCT WITHIN THE PACKAGES WAS CORRECT . A DEVICE HISTORY REVIEW DID NOT REVEAL ANY ANNOTATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS RELATED TO THIS ISSUE. ALL LOTS, 1901013, 1808018 , 1906017 WERE MANUFACTURED AND SENT FOR STERILIZATION DURING SEPARATE MONTHS, NEVER BEING HOUSED WITHIN THE FACILITY DURING THE SAME TIME. PRODUCT UNDERGOES VISUAL INSPECTIONS PRIOR TO RELEASE, INCLUDING VERIFYING THE PROPER PRODUCT AND QUANTITY IS WITHIN EACH PACKAGE. ALL INSPECTIONS FOR THESE LOTS WERE COMPLETED ACCORDING TO PROCEDURE, NO ANNOTATIONS WERE NOTED RELATED TO THE REPORTED INCIDENT. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 23G WERE FOUND IN THE BOX OF 50 WHITACRE SET 25GA 3.50 IN FOR INDIA NEEDLES, BOTH IN LOTS 1901013 AND 1808018. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WRONG PRODUCT (SPINAL NEEDLE 23G-405120) INSIDE THE BOX OF WHITACRE 25G-405129. DURING SUPPLY OF 4 BOX I.E. 100 UNITS OF BD WHITACARE 25G OF REF NO-405129 TO A CUSTOMER, DISTRIBUTOR HAD FOUND BD SPINAL 23G OF REF NO-405120 INSIDE ALL THE BOXES INSTEAD OF WHITACARE 25G. OUTER PART OF THE BOX WERE OF BD WHITACARE 25G WITH BATCH NO-1901013 & 1808018 EACH CONTAINING 50 UNITS. BUT INSIDE EACH BOX THEY HAD FOUND BD SPINAL 23G, LOT NO-1906017."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1901013, MEDICAL DEVICE EXPIRATION DATE: 2023-12-31, DEVICE MANUFACTURE DATE: 2019-01-29. MEDICAL DEVICE LOT #: 1808018, MEDICAL DEVICE EXPIRATION DATE: 2023-07-31, DEVICE MANUFACTURE DATE: 2018-08-31. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 23G WERE FOUND IN THE BOX OF 50 WHITACRE SET 25GA 3.50 IN FOR INDIA NEEDLES, BOTH IN LOTS 1901013 AND 1808018. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WRONG PRODUCT (SPINAL NEEDLE 23G-405120) INSIDE THE BOX OF WHITACRE 25G-405129 DURING SUPPLY OF 4 BOX I.E. 100 UNITS OF BD WHITACARE 25G OF REF NO-405129 TO A CUSTOMER, DISTRIBUTOR HAD FOUND BD SPINAL 23G OF REF NO-405120 INSIDE ALL THE BOXES INSTEAD OF WHITACARE 25G. OUTER PART OF THE BOX WERE OF BD WHITACARE 25G WITH BATCH NO-1901013 & 1808018 EACH CONTAINING 50 UNITS. BUT INSIDE EACH BOX THEY HAD FOUND BD SPINAL 23G, LOT NO-1906017."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167835 WHITACRE SET 25GA 3.50 IN FOR INDIA ANESTHESIA CONDUCTION KIT CAZ SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1