MAUDE Adverse Event Report: TELEFLEX HUDSON TUBING, STAR LUMEN, 7'; OXYGEN TUBING

Catalog Number 1112

Device Problems Bent (1059); Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Date 03/20/2014

Event Type  malfunction  

Event Description

The event is reported as: the customer alleges that upon opening the package the staff noted the tubing bent, twisted and crushed.

Manufacturer Narrative

A visual inspection of the product involved in the complaint was performed on a picture provided by the customer.It can be observed a kinked tube.No other issues were found.Dimensional and functional inspection is not required since the reported issue is not related to a dimensional defect.A dhr (device history record) review showed that there were no issues related to this issue neither on the product nor its components during the manufacture of the material.During the visual inspection of the picture provided by the customer and reported defect is confirmed, the product (catalog #1112) has a kinked tube.Regarding the kinked issue, the transportation carts that are currently used to stage the tubing from extrusion into assembly will be improved to avoid kinks during handling.

• Brand Name: HUDSON TUBING, STAR LUMEN, 7'
• Type of Device: OXYGEN TUBING
• Manufacturer (Section D): TELEFLEX; nuevo laredo, tamaulipas ; MX
• Manufacturer Contact: margie burton, rn ; po box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3813228
• MDR Text Key: 4401613
• Report Number: 3004365956-2014-00161
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1112
• Device Lot Number: 02A1400805
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1