MAUDE Adverse Event Report: FLEXICARE MEDICAL DONGGUAN LTD. PAEDIATRIC PARALLEL CIRCUIT 96" Y-PIECE LUER ELBOW 2 X B/VIRAL FILTERS 1L R BAG; PAEDIATRIC ANAESTHESIA CIRCUIT

Model Number 038-02-713U

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2019

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

The seam on the side of the tubing failed and cause of failure to be able to ventilate ab anesthetized patient.

• Brand Name: PAEDIATRIC PARALLEL CIRCUIT 96" Y-PIECE LUER ELBOW 2 X B/VIRAL FILTERS 1L R BAG
• Type of Device: PAEDIATRIC ANAESTHESIA CIRCUIT
• 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: 8412557
• MDR Text Key: 138546521
• Report Number: 3006061749-2019-00006
• 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: health professional
• Reporter Occupation: Nurse
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 038-02-713U
• Device Catalogue Number: 038-02-713U
• Device Lot Number: 180701295
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2018
• 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