MAUDE Adverse Event Report: TELEFLEX MEDICAL; CIRCUIT, BREATHING (W CONNECTO

Catalog Number 1613

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned at the time of this report.The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.Dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided.No corrective actions can be established.In order to perform a proper and thorough investigation to confirm the alleged defect, determine a root cause and establish corresponding corrective actions, it is necessary to evaluate the sample involved.If the device sample becomes available at a later date this complaint will be updated accordingly.

Event Description

Customer complaint alleges "the circuit pressure test would quickly fail each attempt.We isolated the problem to the expiratory limb of the circuit and slowly inspected the circuit until we felt the leak.There are pinhole tears in the seam of the product." alleged defect reported as detected during testing prior to patient use.No patient involvement reported.

Manufacturer Narrative

Qn# (b)(4).One (1) ventilator tubing set, long length, product code 1613, 6 feet long was received for investigation.A visual exam was performed and there were no signs of abuse/misuse/damage.The 6 foot section of tubing was placed on a calibrated leak tester.Both ends of the tubing set are identical.Approximately 16 inches from one end, identified with blue pin ink from the customer, is a short series of what appears to be tears, which evolved into a puncture (hole) in the tubing.Once the tube set was submerged into a bath of water with the prescribed amount of air pressure, a profuse leak was discovered via bubbling.The leak was so profuse a leak value could not established by the leak tester.The leak rate specification is governed by iso 5367, 2014, annex e, which specifies an adult circuit under 60 +- 3 cmh2o of air pressure, cannot exceed a leak rate greater than 70 ml/min.Based on the investigation performed, the reported complaint was confirmed.The damage (hole) does not appear to have been caused by a manufacturing process.The tear/s are across the top of the ribs and then evolves into a hole (puncture).This damage appears to have been caused during use.All circuit tubing is inspected and leak tested 100% at the manufacturing facility; thus a defect such as this would be detected prior to release.

Event Description

Customer complaint alleges "the circuit pressure test would quickly fail each attempt.We isolated the problem to the expiratory limb of the circuit and slowly inspected the circuit until we felt the leak.There are pinhole tears in the seam of the product." alleged defect reported as detected during testing prior to patient use.No patient involvement reported.

• Type of Device: CIRCUIT, BREATHING (W CONNECTO
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7502686
• MDR Text Key: 107992893
• Report Number: 3004365956-2018-00150
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2018

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: 1613
• Device Lot Number: 74A1800825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2018
• Initial Date FDA Received: 05/10/2018
• Supplement Dates Manufacturer Received: 06/18/2018
• Supplement Dates FDA Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2018
• 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