MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON BREATH CIRC,ANES,ADULT,EXP 0.5-1.8M; CIRCUIT, BREATHING (W CONNECTO

Catalog Number 311403

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: "y connector disconnects during ventilation".No patient injury reported.

Manufacturer Narrative

(b)(4).Corrected data: section b.3.-date of event corrected to (b)(6) 2019.Received one (1) 311403 breath circ,anes,adult,exp 0.5-1.8m w/ex, for investigation.The circuit was in a sealed package.Upon receipt the sample was visually examined for any signs of abuse/misuse/damage.Nothing noted.The complaint states the circuit disconnects at the patient ventilation.The inside and outside 15mm connection points at the wye connector were tested with go/no go gages.These devices are specified to have iso 5356-1 standard 15mm connections.The calibrated gauges were placed into each sample with the specified 35n or 7.9lbs force for the 15mm connections.After the tests above were performed, it was determined the sample was within specification for 15mm connections intended for ventilator circuit use.The complaint could not be confirmed with the sample provided.The device history record of batch number 74c1800775 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specification.

Event Description

The complaint is reported as: "y connector disconnects during ventilation".No patient injury reported.

• Brand Name: HUDSON BREATH CIRC,ANES,ADULT,EXP 0.5-1.8M
• Type of Device: CIRCUIT, BREATHING (W CONNECTO
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8583423
• MDR Text Key: 144172516
• Report Number: 3004365956-2019-00107
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 311403
• Device Lot Number: 74C1800775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Date Manufacturer Received: 05/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED; NONE REPORTED