MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON VENTILATOR TUBING SET,LONG LENGTH; CIRCUIT, BREATHING (W CONNECTO

Catalog Number 1607

Device Problem Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 06/15/2020

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

Customer reported the circuit would not pass the sst pressure test.No patient involvement reported.

Event Description

Customer reported the circuit would not pass the sst pressure test.No patient involvement reported.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.The circuit was hooked up to the leak tester and was leak tested against iso standard 5367:2014, annex e, which specifies an adult circuit under 60 +/- 3 cmh2o of air pressure, cannot exceed a leak rate greater than 70ml/min.The reading on the leak tester was 210 ml/min which is over the iso requirement.After the functional inspection , the blue temperature port was found to be deformed.The circuit was found to leak from the blue temperature port due to it being deformed.A device history record review was performed and no relevant findings were identified.Based on the investigation performed the complaint was confirmed.There is not sufficient evidence to assure this damage was originated during the manufacturing process.The root cause for the issue could not be identified.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: HUDSON VENTILATOR TUBING SET,LONG LENGTH
• Type of Device: CIRCUIT, BREATHING (W CONNECTO
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10232820
• MDR Text Key: 197577727
• Report Number: 3004365956-2020-00127
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

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: No Information
• Device Catalogue Number: 1607
• Device Lot Number: 74D2002305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 07/06/2020
• Supplement Dates Manufacturer Received: 07/16/2020
• Supplement Dates FDA Received: 07/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1