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

Catalog Number 7140

Device Problem Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 01/24/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The lot number reported was not valid, therefore a device history record review was performed on potential lot number 74e1900009 and no relevant findings were identified.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

Customer reported an air leak was found during pre-test of device, prior to use.No patient involvement reported.

Manufacturer Narrative

(b)(4).The customer returned one 7140 adult breathing circuit and reservoir bag for evaluation.The breathing circuit and bag were visual inspected for signs of misuse/abuse/neglect.Nothing was noted.The circuit was hooked up to a 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 16 ml/min which is well under the iso requirement.The reservoir bag was also tested for leaks buy submerging it in water.No leaks were found.The device history record of batch number 74e1900009 was 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 specifications.Based on the investigation performed, the complaint was confirmed.Functional testing did not reveal any operational anomalies.The circuit was found to be leaking at a rate of 16 ml/min which is well under the iso requirement for an adult circuit of 70ml/min.No further testing required.Teleflex will continue to monitor and trend complaints of this nature.

Event Description

Customer reported an air leak was found during pre-test of device, prior to use.No patient involvement reported.

• 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: 9699797
• MDR Text Key: 198504220
• Report Number: 3004365956-2020-00037
• 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: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2020
• 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: 74E1900009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Date Manufacturer Received: 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.