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

Catalog Number 1680

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 12/07/2015

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.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 (b)(4) (corr-a-flex tubing,100 ft roll) batch 74j1500851 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 sections of the flex tubing were returned for evaluation.A visual exam was performed and no defects were observed.Functional testing was performed and one of the sections did not pass the leak testing.It was found that the leak was from a very small pin hole which was detected with a soluble soap leak detector.Based on the investigation performed, the reported complaint was confirmed.Although the complaint was confirmed, a root cause for the pin hole could not be determined.A conclusion code could not be chosen as the complaint was confirmed however a root cause was not established.

Event Description

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

Manufacturer Narrative

(b)(4).No 'conclusions' code (blank).A conclusion code could not be found.The complaint was confirmed; however, a root cause was not established.

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: 5358321
• MDR Text Key: 35611643
• Report Number: 3004365956-2016-00072
• 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,Followup
• Report Date: 01/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2016
• 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: 74J1500851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2015
• 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