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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MCKESSON MEDICAL-SURGICAL INC MCKESSON COAXIAL PEDIATRIC CIRCUIT CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)

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MCKESSON MEDICAL-SURGICAL INC MCKESSON COAXIAL PEDIATRIC CIRCUIT CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) Back to Search Results
Model Number 16-C60P
Device Problems Obstruction of Flow (2423); Material Twisted/Bent (2981)
Patient Problem Dyspnea (1816)
Event Date 08/24/2022
Event Type  Injury  
Event Description
Reference report # mw5111730; 8 year old with autism having general anesthesia for full mouth dental rehabilitation. Anesthesia circuit pressure checked prior to use. During inhalation induction of anesthesia with 8% sevoflurane and 70% nitrous oxide after oral midazolam premedication, the patient was slow to attain adequate depth of anesthesia and complained that it was hard to breathe through mask. The inspired sevoflurane concentration read 1. 5 and the exhaled 0. 6 despite 8% sevoflurane on dial and no disconnect. This was identical to a situation we had on (b)(6) 2022, reported (b)(6) 2022 to fda and the anesthesia circuit was immediately changed which allowed a normal induction of anesthesia and attaining sevoflurane concentrations of 5-6%. On inspection of the mckesson coaxial pediatric circuit. There was a twist in the distal inner (inspiratory) limb causing a greater than 75% obstruction to airflow- identical to the case the day before (see picture attached). The patient did well with the procedure without complication but could have had significant respiratory or cardiorespiratory complications had the obstructed circuit not been quickly recognized. This event was reported to mckesson and the information disseminated throughout the entire blue cloud pediatric surgery center organization including lot number ending in t99 and plan to recognize defective circuits and utilize circuits of different lot, mif possible. Please note that the fda medwatch voluntary report fro (b)(6) 2022 was incorrect. The circuit used in both cases was the mckesson pediatric coaxial circuit 16-c60p. The circuit on (b)(6) was not the adult 16-c72 as originally described to fda medwatch. Fda safety report id# (b)(4).
 
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Brand NameMCKESSON COAXIAL PEDIATRIC CIRCUIT
Type of DeviceCIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
Manufacturer (Section D)
MCKESSON MEDICAL-SURGICAL INC
1125 sycamore road
manteno IL 60950
MDR Report Key15320841
MDR Text Key298989291
Report NumberMW5111769
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 08/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model Number16-C60P
Device Lot NumberMWM121421T99
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/29/2022 Patient Sequence Number: 1
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