MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON TUBING,STAR LUMEN,50'; PRESSURE TUBING & ACCESSORIES

Catalog Number 1120

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record of batch number 74a1603236 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled & inspected according to our specifications.Customer complaint cannot be confirmed due the lack of sample.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility and it is not being manufactured at the time.If the device sample becomes available this investigation will be updated with the evaluation results.

Event Description

The end-user alleges that the oxygen tubing is kinking and cutting off her flow of oxygen.No patient injury or consequence reported.

• Brand Name: HUDSON TUBING,STAR LUMEN,50'
• 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: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 5783705
• MDR Text Key: 49233226
• Report Number: 3004365956-2016-00269
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2021
• Device Catalogue Number: 1120
• Device Lot Number: 74A1603236
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1