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

Catalog Number 1680

Device Problem Fitting Problem (2183)

Patient Problem No Patient Involvement (2645)

Event Date 03/10/2016

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 for review.The device history record review showed that there were no issues related to functional issues on the corrugated component involved in this complaint during the manufacture of the material for lot # 74l1403453.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 product feels different and the tubing does not seal on the ventilator and causes a diagnostic failure.The alleged failure was detected during the pre-test.

• 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: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 5529131
• MDR Text Key: 41254988
• Report Number: 3004365956-2016-00175
• 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
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 74L1403453
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2016
• Initial Date FDA Received: 03/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: VENTILATOR