MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON CIRCUIT, HTD DUAL LIMB W/WATER TRAPS W/O; BREATHING CIRCUIT

Catalog Number 780-36

Device Problems Hole In Material (1293); Cut In Material (2454)

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

Event Date 04/01/2015

Event Type  malfunction  

Event Description

The customer alleges that the circuit had nicks/holes that were found during pre-testing.No pt injury.

Manufacturer Narrative

(b)(4).It is unk if the device is available for eval.A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not received at our facility.Thas an add'l test, (b)(4) samples of current production p/n 780-36 (circuit, htd dual limb w/water traps w/o) were reviewed and inspected for holes and tested according to tp-0145, and no issues were found than can lead to the condition reported by the customer.A dhr review could not be conducted since the lot number was not provided.No corrective actions can be established at this moment since the device sample or picture is not available for eval.Customer complaint cannot be confirmed based only on the info provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint.If device sample becomes available at a later date, this complaint will be re-opened.

• Brand Name: HUDSON CIRCUIT, HTD DUAL LIMB W/WATER TRAPS W/O
• Type of Device: BREATHING CIRCUIT
• Manufacturer (Section D): TELEFLEX MEDICAL; rtp NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo, tamaulipas 8827 5; MX 88275
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4736405
• MDR Text Key: 5706332
• Report Number: 3004365956-2015-00133
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 780-36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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