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

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).

• Brand Name: MCKESSON COAXIAL PEDIATRIC CIRCUIT
• Type of Device: CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
• Manufacturer (Section D): MCKESSON MEDICAL-SURGICAL INC; 1125 sycamore road; manteno IL 60950
• MDR Report Key: 15320841
• MDR Text Key: 298989291
• Report Number: MW5111769
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• 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 Received: 08/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 16-C60P
• Device Lot Number: MWM121421T99
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 8 YR
• Patient Sex: Male
• Patient Weight: 33 KG