MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON HUMID-VENT FILTER COMPACT STR STERILE

Catalog Number G19401

Device Problems Partial Blockage (1065); Restricted Flow rate (1248)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2015

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.

Event Description

The customer alleges that the filter was blocked and did not allow respiration.The filter was changed without issue.No patient injury reported.

Manufacturer Narrative

(b)(4).A device history record (dhr) review was performed and there were no issues found that could relate to the reported complaint.The device was manufactured according to release specification.The device was returned for evaluation.A visual exam was performed and it was observed that the sample was assembled correctly.A drop test could not be conducted as the sample was received wet.The instructions for use (ifu) mentions that filters should not be used with patients producing fulminating frothy secretions within their airways, or patients with hemoptysis.The filter is to be replaced immediately if there is increasing resistance or any suspicion of contamination, occlusion, or other indications of malfunction present.In addition, to prevent accumulation of condensation, position the filter to allow water to drain away from the upstream side of the filter.Based on the investigation performed, the reported complaint could not be confirmed.The customer complained that the product was blocked; however, based on the visual inspection, the product was assembled correctly.Drop testing could not be conducted as the returned sample was wet.In the current manufacturing procedure, a drop test and other remarks: visual inspection after assembly of the product is conducted; therefore, any ineffective products would be detected during this process.

Event Description

The customer alleges that the filter was blocked and did not allow respiration.The filter was changed without issue.No patient injury reported.

• Brand Name: HUDSON HUMID-VENT FILTER COMPACT STR STERILE
• Type of Device: HUMID-VENT FILTER
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL; po box 28, kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5018515
• MDR Text Key: 23606749
• Report Number: 8040412-2015-00177
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: G19401
• Device Lot Number: 15CT11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2015
• 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