MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON VENTILATOR TUBING SET,LONG LENGTH; UNIVERSAL VENT TUBING/BREATHING CIRC

Catalog Number 1607

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device sample involved in this incident was discarded by the user facility.A representative sample from the same lot# will be sent for investigation.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 (dhr) of batch number 74j1501818 that belong to catalog number 1607 has been reviewed and no issues or discrepancies were found which could potentially be related to this complaint.Dhr shows that the product was assembled & inspected according to our specifications.No corrective action can be established at this moment since the device sample or picture are not available for evaluation.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.If the device sample becomes available at a later date this complaint will be re-opened.

Event Description

The customer alleges that the tubing disconnected during use on a patient.No patient injury reported.

• Brand Name: HUDSON VENTILATOR TUBING SET,LONG LENGTH
• Type of Device: UNIVERSAL VENT TUBING/BREATHING CIRC
• 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: 5307002
• MDR Text Key: 33778240
• Report Number: 3004365956-2015-00420
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1607
• Device Lot Number: 74J1501818
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2015
• 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