BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KELLER FUNNEL2 (5PK)

    MDR report key: 18793071 · Received February 27, 2024

    Report

    Report Number
    3011299751-2024-00037
    Event Type
    Malfunction
    Date Received
    February 27, 2024
    Date of Event
    January 25, 2024
    Report Date
    August 19, 2024
    Manufacturer
    ALLERGAN (KELLER)
    Product Code
    KDD
    PMA / PMN Number
    510(K)EXEMPT
    Removal / Correction Number
    Z-1694-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED E1 (EMAIL ADDRESS): (B)(4) A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE REASON FOR REPORT: LUBRICATED AS NORMAL, HOWEVER, THE LINING OF THE FUNNEL SEEMED TO BE DEFECTIVE - NOT ALLOWING THE IMPLANT TO PROGRESS THRU TO THE TIP OF THE FUNNEL.

    Additional Manufacturer Narrative · 0

    LAB INVESTIGATION: THE SAMPLE WAS INVESTIGATED. NO DAMAGE WAS OBSERVED. A COATING EVALUATION WAS PERFORMED. THE INTERIOR SURFACE OF THE FUNNEL WAS NOT OBSERVED TO BE LUBRICIOUS, WHICH DOES NOT MEET THE EXPECTED RESULT. THE EXTERIOR SURFACE OF THE FUNNEL WAS NOT OBSERVED TO BE LUBRICIOUS, WHICH MEETS THE EXPECTED RESULT. A LUBRICITY/ FUNCTIONAL EVALUATION WAS NOT PERFORMED SINCE THE INTERIOR SURFACE WAS NOT OBSERVED TO BE LUBRICOUS. THE PROBABLE CAUSE FOR THE INTERIOR SURFACE OF THE FUNNEL TO NOT BE LUBRICIOUS IS UNKNOWN; HOWEVER, A MANUFACTURING ERROR IS SUSPECTED. ABBVIE DEVICE QUALITY ASSURANCE (DQA) WAS NOTIFIED OF THE CONDITION OF THE SAMPLE. PER DISCUSSION AND REVIEW WITH DQA, THE CURRENT COMPLAINT SAMPLE IS ASSOCIATED WITH KELLER FUNNEL BATCH 23B42C. A RECALL FOR KELLER FUNNEL BATCH 23B42C WAS INITIATED BY FORMACOAT. NO FURTHER EVALUATION IS REQUIRED INVESTIGATION RESULT: THE CATEGORY/SUBCATEGORY OF MECHANICAL ISSUE - LUBRICITY WAS VERIFIED BASED ON THE TEST RESULTS IN THE SAMPLE INVESTIGATION. CONCLUSION THE CATEGORY/SUBCATEGORY OF MECHANICAL ISSUE - LUBRICITY WAS VERIFIED SINCE THE INTERIOR SURFACE OF THE FUNNEL WAS NOT OBSERVED TO BE LUBRICIOUS DURING THE COATING EVALUATION. A LUBRICITY/ FUNCTIONAL EVALUATION WAS NOT PERFORMED SINCE THE INTERIOR SURFACE WAS NOT OBSERVED TO BE LUBRICOUS. THE PROBABLE CAUSE FOR THE INTERIOR SURFACE OF THE FUNNEL TO NOT BE LUBRICIOUS IS UNKNOWN; HOWEVER, A MANUFACTURING ERROR IS SUSPECTED. ABBVIE DEVICE QUALITY ASSURANCE (DQA) WAS NOTIFIED OF THE CONDITION OF THE SAMPLE. PER DISCUSSION AND REVIEW WITH DQA, THE CURRENT COMPLAINT SAMPLE IS ASSOCIATED WITH KELLER FUNNEL BATCH 23B42C. A RECALL FOR KELLER FUNNEL BATCH 23B42C WAS INITIATED BY FORMACOAT. NO FURTHER EVALUATION IS REQUIRED.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED, "THE FUNNEL WAS CUT AND LUBRICATED AS NORMAL HOWEVER THE LINING OF THE FUNNEL SEEMED TO BE DEFECTIVE - NOT ALLOWING THE IMPLANT TO PROGRESS THRU TO THE TIP OF THE FUNNEL." SURGERY COMPLETED WITH A BACKUP FUNNEL.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED, "THE FUNNEL WAS CUT AND LUBRICATED AS NORMAL HOWEVER THE LINING OF THE FUNNEL SEEMED TO BE DEFECTIVE - NOT ALLOWING THE IMPLANT TO PROGRESS THRU TO THE TIP OF THE FUNNEL." SURGERY COMPLETED WITH A BACKUP FUNNEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657367 KELLER FUNNEL2 (5PK) KIT, SURGICAL INSTRUMENT, DISPOSABLE KDD ALLERGAN (KELLER) 23B42C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female