BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALLARD CLOSED SUCTION SYSTEM

    MDR report key: 21067907 · Received January 3, 2025

    Report

    Report Number
    8030647-2025-00002
    Event Type
    Injury
    Date Received
    January 3, 2025
    Date of Event
    December 3, 2024
    Report Date
    May 22, 2025
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    BSY
    UDI-DI
    00609038938240
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL COMPLAINT PRODUCT WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN PROGRESS. 4581- APPROPRIATE TERM/CODE NOT AVAILABLE- DECREASED HEART RATE. ALL INFORMATION REASONABLY KNOWN AS OF 03 JAN 2025 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    CORRECTION: G1. ADDITIONAL INFORMATION: D4; H64581- APPROPRIATE TERM/CODE NOT AVAILABLE- DECREASED HEART RATE. PHOTOGRAPHIC /VIDEO EVIDENCE, PROVIDED BY THE REPORTER, WAS REVIEWED AND CONFIRMED THE EVENT AS REPORTED. THE ACTUAL COMPLAINT PRODUCT WAS NOT AVAILABLE FOR RETURN; HOWEVER, AS THIS IS A KNOWN DEVICE PROBLEM EVALUATION OF THE DEVICE WAS NOT NECESSARY. THE ROOT CAUSE IS TRACED TO THE MANUFACTURING PROCESS; MEASURES ARE IN PLACE TO PREVENT THE ISSUE FROM REOCCURRING. THE DEVICE HISTORY RECORD FOR LOT 30327327 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 22 MAY 2025 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUN MED HOLDINGS LLC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2025-00003 FOR THE SECOND REPORT IT WAS REPORTED, AN ATTEMPT TO REPOSITION THE NEONATE ON THE OSCILLATOR VENT WAS MADE; THE BABY RECEIVED SLIGHT CONDENSATION THROUGH THE ENDOTRACHEAL TUBE (ETT) AND THEIR HEART RATE AND OXYGEN SATURATIONS BEGAN TO DROP. AN ATTEMPT TO SUCTION THE NEONATE WITH THE CURRENT 6FRENCH ETT SUCTION AND THE BALLARD WAS MADE; HOWEVER, THE CATHETER KEPT POPPING OFF OF THE Y PIECE (WOULD NOT PASS THE Y INTERFACE), WHICH RESULTED IN CIRCUIT PRESSURE LOSS. AN UNSUCCESSFUL ATTEMPT TO TWIST THE CATHETER INTERNALLY WAS PERFORMED; THE CATHETER WAS REPLACED.

    Description of Event or Problem · 0

    SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 8030647-2025-00003 FOR THE SECOND REPORT. IT WAS REPORTED, AN ATTEMPT TO REPOSITION THE NEONATE ON THE OSCILLATOR VENT WAS MADE; THE BABY RECEIVED SLIGHT CONDENSATION THROUGH THE ENDOTRACHEAL TUBE (ETT) AND THEIR HEART RATE AND OXYGEN SATURATIONS BEGAN TO DROP. AN ATTEMPT TO SUCTION THE NEONATE WITH THE CURRENT 6FRENCH ETT SUCTION AND THE BALLARD WAS MADE; HOWEVER, THE CATHETER KEPT POPPING OFF OF THE Y PIECE (WOULD NOT PASS THE Y INTERFACE), WHICH RESULTED IN CIRCUIT PRESSURE LOSS. AN UNSUCCESSFUL ATTEMPT TO TWIST THE CATHETER INTERNALLY WAS PERFORMED; THE CATHETER WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568439 BALLARD CLOSED SUCTION SYSTEM BALLARD CLOSED SUCTION CATHETER, Y-ADAPTER, NEONATAL/PEDIATRIC BSY AVANOS MEDICAL INC. 93824 30327327 00609038938240

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Female