MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON BREATHING CIRC,ANES,ADULT, 48 IN W/3 LT; CIRCUIT, BREATHING (W CONNECTO

Catalog Number 7140

Device Problems Crack (1135); Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 04/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

It was reported that air leaked during the test before use.The user found 2 cracks on the tube near the connector to the anesthesia system.Therefore, a new unit was used instead.No patient involvement reported.

Event Description

It was reported that air leaked during the test before use.The user found 2 cracks on the tube near the connector to the anesthesia system.Therefore, a new unit was used instead.No patient involvement reported.

Manufacturer Narrative

(b)(4).The customer returned one 7140 breathing circuit and reservoir bag for evaluation.The breathing circuit and bag were visually inspected for signs of misuse/abuse/neglect.Red tape was found on both connections opposite the y-connector.The tape was removed, and the tubing was further visually inspected.Nothing was noted.After functional testing, a hole was found in the circuit 2" from the end of the water reservoir connector.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 211 ml/min which is above the iso requirement.The reservoir bag was also tested for leaks by submerging it in a tub of water.No leaks were found.Based on the visual and functional inspection of the sample received, the complaint is confirmed.The sample has a leak on the tubing where the hole was observed in the visual inspection.Although the condition was observed on the sample provided, there is not sufficient evidence to assure that this issue was originated during the manufacturing assembly.Personnel of the molding area and assembly line will be notified for awareness.

• Brand Name: HUDSON BREATHING CIRC,ANES,ADULT, 48 IN W/3 LT
• Type of Device: CIRCUIT, BREATHING (W CONNECTO
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10070874
• MDR Text Key: 196928080
• Report Number: 3004365956-2020-00111
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 7140
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2020
• Date Manufacturer Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1