MAUDE Adverse Event Report: FLEXICARE MEDICAL LIMITED PEDIATRIC FLEXI-LOCK PARALLEL CIRCUIT; CIRCUIT, BREATHING

Catalog Number 038-02-612U

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2019

Event Type  Injury  

Event Description

Pediatric anesthesia circuit leak-checked prior to use.Anesthesia induced on pediatric pt, circuit expanded, and could not ventilate pt due to leak in circuit.Pt ventilated with ambu-bag, and circuit replaced with new one.Original circuit found to have a crack in the tubing.

• Brand Name: PEDIATRIC FLEXI-LOCK PARALLEL CIRCUIT
• Type of Device: CIRCUIT, BREATHING
• Manufacturer (Section D): FLEXICARE MEDICAL LIMITED; mountain ash CF45 4ER; UK CF45 4ER
• MDR Report Key: 8256979
• MDR Text Key: 133538641
• Report Number: MW5083195
• 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: 01/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Catalogue Number: 038-02-612U
• Device Lot Number: 180601433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/16/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 10 YR
• Patient Weight: 43