MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON H-V FILTER SMALL STRAIGHT, STERILE

Catalog Number G19501

Device Problems Complete Blockage (1094); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2014

Event Type  malfunction  

Event Description

The customer alleges that after the operation, the doctor found the black substances on the filter of the humid-vent.Also, the same substances were observed on the filter of the anesthesia apparatus connected to the humid-vent.Both filters appeared to be clogged.No abnormality was found before use.The pt's condition is reported as fine.

Manufacturer Narrative

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

• Brand Name: HUDSON H-V FILTER SMALL STRAIGHT, STERILE
• Type of Device: H-V FILTER
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia ; MY
• Manufacturer (Section G): TELEFLEX MEDICAL; p.o. box 28, kamunting industrial estate; perak, west malaysia 3460 0 MY; MY 34600 MY
• Manufacturer Contact: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 4262347
• MDR Text Key: 17632150
• Report Number: 8040412-2014-00261
• Device Sequence Number: 1
• Product Code: CAH
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/30/2014

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: Health Professional
• Device Catalogue Number: G19501
• Device Lot Number: 14GT12J
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2014
• Initial Date FDA Received: 11/06/2014
• 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