MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON TUBING, OXYGEN SUPPLY 7'; PRESSURE TUBING & ACCESSORIES

Catalog Number 1115

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

Event Description

The customer alleges that the oxygen supply tubing kinked during use.No patient injury reported.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no kinking was observed on the tubing.Functional testing was also performed and no issues were found.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.

Event Description

The customer alleges that the oxygen supply tubing kinked during use.No patient injury reported.

• Brand Name: HUDSON TUBING, OXYGEN SUPPLY 7'
• Type of Device: PRESSURE TUBING & ACCESSORIES
• 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: 5885800
• MDR Text Key: 52414035
• Report Number: 3004365956-2016-00304
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1115
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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