MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON BREATHING CIRC,ANES,PED,60" W/1L BAG; BREATHING CIRCUIT

Catalog Number 353901

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/09/2013

Event Type  malfunction  

Event Description

The complaint was reported as: the customer alleges that there is a crack on the distal end of the device at the connector.No report of a pt injury or delay in treatment.

Manufacturer Narrative

Two pictures of the unit of catalog number 353901 (breathing circ,anes,ped,60" w/1l bag) were received for analysis.They were visually inspected finding a crack in the corrugated tubing p/n 10669-05 (corrugated tubing,15 x 22 mm,60) as is described in the complaint description.A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.A dhr (device history record) review could not be conducted since the lot number was not provided.The customer complaint is confirmed based on the received pictures.The received pictures shows a crack in the corrugated tubing as is described in the complaint description.The root cause is unknown.As a corrective action the personnel involved on the manufacturing process were notified of this issue.Add to this, the actual inventory of the corrugated tubing involved in this complaint (p/n 10669-05) was inspected for crack issues and no issues were detected.Based on complaint history review this is considered an isolated event.(b)(4) facility will continue to track and trend this type of complaint.

• Brand Name: HUDSON BREATHING CIRC,ANES,PED,60" W/1L BAG
• Type of Device: BREATHING CIRCUIT
• Manufacturer (Section D): TELEFLEX MEDICAL; nuevo laredo ; MX
• Manufacturer (Section G): TELEFLEX; ave. transformacion 5954; parque industrial finsa; nuevo laredo 8827 5; MX 88275
• Manufacturer Contact: margie burton, clinical speciali ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3769246
• MDR Text Key: 4439710
• Report Number: 3004365956-2014-00012
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/26/2013

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: Other
• Device Catalogue Number: 353901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/26/2013
• Initial Date FDA Received: 01/09/2014
• 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