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

Catalog Number 1115

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2016

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.No photo available for review.The device history record of batch number 74g1502586 that belongs to catalog number 1115 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled & inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint.However material from the production line was inspected and no issues were detected that can lead this customer complaint.If the device sample becomes available at a later date this complaint will be re-opened.

Event Description

The customer alleges that the tubing leaks at the area where the tubing and connector are glued together.This results in a leak and the medication is no longer delivered.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was also performed and the sample passed the leak testing.No issues were detected.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.The product was assembled and inspected according to specifications.

Event Description

The customer alleges that the tubing leaks at the area where the tubing and connector are glued together.This results in a leak and the medication is no longer delivered.

• Brand Name: HUDSON TUBING, OXYGEN SUPPLY 7'
• Type of Device: PRESSURE TUBING
• 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: 5503507
• MDR Text Key: 40402231
• Report Number: 3004365956-2016-00148
• 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: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/23/2020
• Device Catalogue Number: 1115
• Device Lot Number: 74G1502586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2015
• 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