MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON BREATH CIRC,ANES,ADULT,EXP 0.5-1.8M W/E; ANESTHESIA BREATHING CIRCUIT

Catalog Number 311403

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 05/26/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Five pictures of catalog number 311403 were received for analysis.They were visually inspected but the pictures are not clear enough to identify any issue that can lead to this defect.It is necessary to have the sample to perform an investigation.The device history record of batch number 74j1401555 that belongs to catalog number 311403 has been reviewed and no issues or discrepancies were found which could potentially be related to this 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 our specifications.No corrective action can be established since the sample is not available to perform an investigation and determine the source of defect reported.Customer complaint cannot be confirmed based only on the information provided, the pictures are not clear enough to identify any issue that can lead to this defect.However, 13 samples of current production p/n 311403 (breath circ, anes,adult,exp 0.5-1.8m w/ex) were reviewed and inspected for cracks in the extension tube and no issues were found that can lead to the condition reported by the customer.If device sample becomes available at a later date this complaint will be re-opened.

Event Description

The customer alleges that during pre-testing a crack was found in the system and an air leak was present.No patient injury reported.

• Brand Name: HUDSON BREATH CIRC,ANES,ADULT,EXP 0.5-1.8M W/E
• 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: 5351147
• MDR Text Key: 35279993
• Report Number: 3004365956-2016-00043
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 311403
• Device Lot Number: 74J1401555
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/11/2014
• 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