MAUDE Adverse Event Report: FLEXICARE MEDICAL DONGGUAN LTD. PAEDIATRIC FLEXI-LOCK PARALLEL CIRCUIT 96" WITH Y-PIECE LUER ELBOW MINI FILTER; ANESTHESIA BREATHING CIRCUIT - EXPANDABLE

Model Number 038-02-612U

Device Problem Fracture (1260)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

Root cause: brittleness of tubing material.Corrective actions: increase level of plasticiser (eva), modification to mold tool to remove any sharp edges, increased qa/operator inspection.

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: PAEDIATRIC FLEXI-LOCK PARALLEL CIRCUIT 96" WITH Y-PIECE LUER ELBOW MINI FILTER
• Type of Device: ANESTHESIA BREATHING CIRCUIT - EXPANDABLE
• Manufacturer (Section D): FLEXICARE MEDICAL DONGGUAN LTD.; no. b-15 xicheng ind zone 1; hengli town; dongguan city, guangdong 52346 0; CH 523460
• Manufacturer (Section G): FLEXICARE MEDICAL DONGGUAN LTD.; no. b-15 xicheng ind zone 1; hengli town; dongguan city, guangdong 52346 0; CH 523460
• Manufacturer Contact: richard downs ; cynon valley business park; mountain ash, rct CF45 -4ER ; UK CF45 4ER
• MDR Report Key: 8365571
• MDR Text Key: 137384118
• Report Number: 3006061749-2019-00001
• Device Sequence Number: 1
• Product Code: OFP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 038-02-612U
• Device Catalogue Number: 038-02-612U
• Device Lot Number: 180601433
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention