MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON BREATHING CIRC,ANES,ADULT,2.4M (96"); ANESTHESIA BREATHING CIRCUIT

Catalog Number 351600

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 10/21/2016

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.A dhr review could not be conducted since the lot number provided (pr0200043165) is not a valid lot number at teleflex (b)(4).No corrective action can be established at this moment since the product sample is 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.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility neither is it being manufactured at the time.If the device sample becomes available at a later date this complaint will be updated.

Event Description

The customer alleges that the tube appears to have a leak in it, showing as faulty on the anesthetic machine.

Manufacturer Narrative

(b)(4).Lot number was corrected to 74e1600018.A device history record (dhr) review was performed on lot number 74e1600018 and there were no issues found that could relate to the reported complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled and inspected according to specification.The sample was returned for evaluation.A visual exam was performed and no tube melting or charring was detected.The entire circuit was leak tested.In order to thoroughly capture all leaks, if any, both limbs of the circuit were submerged under a bath of plain tap water to see if any bubbles could be detected from leaks.Approximately twelve inches from the wye connector end of one circuit the leak was so profuse an acceptable rate of leakage was unattainable.The leakage was coming from one hole.After removing the circuit from the test bath the circuit was reviewed again for any visual damage, this time the damage could be seen with the naked eye.Other remarks: the reported complaint of a leaking circuit was confirmed based upon the sample received.The returned circuit was confirmed to leak as a result of a small puncture like hole in the corrugated tubing material.A dhr review was performed on the product with no evidence to suggest a manufacturing related cause.The defect was discovered prior use in a test environment.Based upon the time of discovery and the damage observed on the returned sample, a definitive root cause could not be established.A conclusion code could not be chosen as the complaint was confirmed; however, a root cause was not determined.

Event Description

The customer alleges that the tube appears to have a leak in it, showing as faulty on the anesthetic machine.

• Brand Name: HUDSON BREATHING CIRC,ANES,ADULT,2.4M (96")
• Type of Device: ANESTHESIA BREATHING CIRCUIT
• 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: 6077104
• MDR Text Key: 59117957
• Report Number: 3004365956-2016-00398
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 351600
• Device Lot Number: PR0200043165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: ANESTHETIC MACHINE