MAUDE Adverse Event Report: TELEFLEX HUDSON PEDIATRIC BREATHING CIRCUIT, HEATED

Catalog Number 780-23

Device Problem Cut In Material (2454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/26/2014

Event Type  malfunction  

Event Description

The complaint alleges that there was a cut on the corrugated tube of the circuit.The reported issue was detected prior to pt use.

Manufacturer Narrative

The device history record of batch number # 02g1201687 was reviewed and there were no issues or discrepancies found that could relate to the reported complaint.No non-conformance reports were originated for the lot in question.The dhr shows that the product was assembled and inspected according to specifications.The sample was not returned, however, the customer provided photographs for eval.A visual exam was performed on the photos and it was observed that there was a perforation on a section of the corrugated tubing.The customer complaint is confirmed based on the photos received.Although the complaint was confirmed, a root cause of the perforation could not be determined.All corrugated tubing material is 100% tested at the mfg facility, therefore, a defect of this type would be detected during the leak test.Current inventory of the corrugated tubing at the mfg facility was inspected and no issues were detected.A conclusion code could not be chosen as the complaint was confirmed, however, a root cause was not established.

• Brand Name: HUDSON PEDIATRIC BREATHING CIRCUIT, HEATED
• Type of Device: PEDIATRIC BREATHING CIRCUIT
• Manufacturer (Section D): TELEFLEX; nuevo laredo, tamaulipas ; MX
• Manufacturer Contact: katharine tarpley ; po box 12600; rtp, NC 27709 ; 9194334854
• MDR Report Key: 4001264
• MDR Text Key: 19925851
• Report Number: 3004365956-2014-00256
• Device Sequence Number: 1
• Product Code: CAG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 780-23
• Device Lot Number: 02G1201687
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/03/2014
• Initial Date FDA Received: 07/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1