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

Catalog Number 1680

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

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 11/13/2015

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 was reviewed showed that there were no issues related to functional issues on the corrugated component involved in this complaint (b)(4) 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 tubing (used as a circuit) has micro holes causing a ventilator check failure.No patient injury or harm.The alleged issue detected during the pre-testing.

Manufacturer Narrative

(b)(4).One unit of catalog number 1680 (corr-a-flex tubing, 100 ft roll), cut into two parts, was received for analysis.A visual exam was performed and no issues were observed.A dimensional inspection was performed in order to assure that the diameters and wall thickness of the components met specification.No issues were found.Leak testing was also performed and the samples passed the test.As an additional test the tubes were submerged under water to verify if a leak was present.No leaking was found.Based on the investigation performed, the reported complaint could not be confirmed.The samples passed all visual, dimensional, and functional testing.Although the complaint was not confirmed, personnel involved in the manufacturing of this product have been notified of the event and a containment action has taken place at the manufacturing site in order to detect similar issues during the extrusion of the tube.A 100% pin hole detector has been installed at the output of the extruder machine since august 31, 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 tubing (used as a circuit) has micro holes causing a ventilator check failure.No patient injury or harm.The alleged issue detected during the pre-testing.

• Brand Name: HUDSON CORR-A-FLEX TUBING,100 FT ROLL
• Type of Device: TUBING AND SUPPORT VENTILATOR
• 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: 5258432
• MDR Text Key: 32527697
• Report Number: 3004365956-2015-00357
• 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: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2015
• 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: 74L1403455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2014
• 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