MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON HUMID-VENT HEPA, WHT LC, STERILE; FILTER, BACTERIAL, BREATHING CIRCUIT

Catalog Number 29001

Device Problem Partial Blockage (1065)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The investigation into this complaint is still in progress at the time of this report.

Event Description

Customer complaint alleges "filter is immediately blocked and the patient cannot be ventilated." there was no report of patient injury or consequence.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).The sample was not returned; therefore ten pieces of the same catalog number in current production were selected for evaluation.All ten samples passed the drop test.The instructions for use (ifu) for this product states that the position of the patient side of the connector of the humid-vent hepa filter should be higher than the et tube connector to avoid accumulation of secretions.Also, do not add moisture to the humid-vent hepa.Replace the unit immediately if there is increasing resistance, if it is soiled with secretions or otherwise obstructed.At the manufacturing site, 100% drop testing is conducted on this product; thus the drop tester will reject the device if there is any type of blockage.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Customer complaint alleges "filter is immediately blocked and the patient cannot be ventilated." there was no report of patient injury or consequence.Patient condition reported as "fine".

• Brand Name: HUDSON HUMID-VENT HEPA, WHT LC, STERILE
• Type of Device: FILTER, BACTERIAL, BREATHING CIRCUIT
• 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: 7443351
• MDR Text Key: 106157025
• Report Number: 8040412-2018-00102
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 29001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2018
• 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