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

Catalog Number 1115

Device Problem Kinked (1339)

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

Event Date 03/13/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual inspection of the product involved in the complaint was performed on two pictures provided by the customer.Some marks on the tube were observed, however, no issues can be observed that can lead this customer complaint.In order to perform a proper and thorough investigation to confirm the alleged defect reported and determine a root cause, it is necessary to evaluate the sample involved in this complaint.Device sample has not been returned at the time of this report.The device history record (dhr) has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.The dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided.If the sample becomes available this investigation will be updated with the evaluation results.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

Customer complaint alleges "tubing kinks where it comes off the wall and collapses making it useless to deliver o2 to patient." alleged defect reported as detected during use.There was no report of patient impact or consequence.Customer submitted photos with the complaint.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and no kinked tubing was observed.The received tubing was found to be within specification.The complaint could not be confirmed as no issues were found.

Event Description

Customer complaint alleges "tubing kinks where it comes off the wall and collapses making it useless to deliver o2 to patient." alleged defect reported as detected during use.There was no report of patient impact or consequence.Customer submitted photos with the complaint.

• Brand Name: HUDSON TUBING, OXYGEN SUPPLY 7'
• Type of Device: TUBING, PRESSURE AND ACCESSORI
• 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: 7379060
• MDR Text Key: 103743663
• Report Number: 3004365956-2018-00086
• 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,health pr
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• 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: 74L1700135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• 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