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 10/27/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

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.

Manufacturer Narrative

(b)(4).Five pictures of catalog number 311403 were received for analysis.They were visually inspected; however, the pictures were not clear enough to identify any issues that could lead to the defect reported.It is necessary to have the sample to perform an investigation.The device history record (dhr) of batch number 74a1501389 that belongs to catalog number 311403 has been reviewed and no issues or discrepancies were 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.The dhr shows that the product was assembled and inspected according to specifications.Thirteen samples of current production (catalog number 311403) were reviewed and inspected for cracks in the extension tube and no issues were found that could lead to the condition reported by the customer.If the defective 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: 5342083
• MDR Text Key: 34998235
• Report Number: 3004365956-2016-00007
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• 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: 74A1501389
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2015
• 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