MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CORR-A-FLEX TUBING,100 FT ROLL; VENTILATOR TUBING

Catalog Number 1680

Device Problem Failure of Device to Self-Test (2937)

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

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

Qn#(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.Device history record review shows that there were no issues related to functional issues on the corrugated component involved in this complaint 1680 (corr-a-flex tubing,100 ft roll) batch 74h1500950 during the manufacture of the material.No corrective action can be established at this moment since the device sample or pictures are not available for evaluation.Customer complaint cannot be confirmed based only on the information provided, to perform a proper investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint.If the device sample becomes available at a later date this complaint will be re-opened.

Event Description

The customer alleges that the circuit failed pre-vent check.No patient injury reported.

Manufacturer Narrative

(b)(4).Two pieces of the sample, catalog number 1680 (corr-a-flex tubing, 100 ft roll), was received for evaluation.A visual exam was performed and no issues were observed.The pieces were measured and it was found that the diameters and wall thickness of the tubes were within specification.Functional testing was also performed and there were no issues detected.The samples passed the leak test.As an additional test, the tubes were submerged under water to verify if a leak was present and there were no air bubbles observed.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned samples.Personnel involved in the manufacture of this product have been notified of this complaint, and a containment action has been placed at the manufacturing site in order to detect similar issues during the extrusion of the tube.A 100% pinhole detector has been installed at the output of the extruder machine as of (b)(4) 2015.This equipment is capable of detecting any pinholes, tears, or any other damage on the body of the tube that could lead to a leak.

Event Description

The customer alleges that the circuit failed pre-vent check.No patient injury reported.

• Brand Name: HUDSON CORR-A-FLEX TUBING,100 FT ROLL
• Type of Device: VENTILATOR 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: 5360018
• MDR Text Key: 36039268
• Report Number: 3004365956-2016-00067
• Device Sequence Number: 1
• Product Code: BZO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial,Followup
• Report Date: 01/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1680
• Device Lot Number: 74H1500950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2015
• 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