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

Catalog Number 1698

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2018

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, or a picture of the alleged defect was not received for evaluation.Trending history review from (b)(6) 2017 to (b)(6) 2018, found no complaints with this same issue for this device or device family.A device history record review could not be conducted since the lot number was not provided.Customer complaint cannot be confirmed due the lack of device sample or a picture of it to perform a proper investigation.Root cause is unknown.No corrective actions can be assigned.Teleflex will continue to monitor customer feedback for complaints of this nature.

Event Description

Customer complaint alleges "respiratory therapist noticed crack on hard plastic connection." alleged defect reported as detected during patient use.Customer reported no patient injury or consequence.

• Brand Name: HUDSON BREATHING CIRCUIT,ADULT,NIV
• 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: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 7682433
• MDR Text Key: 113817291
• Report Number: 3004365956-2018-00217
• 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
• Type of Report: Initial
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1698
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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