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 device involved inthis compalint has been received by the manufacuter, however, the evaluation of said device is still in progress at the time of this report.A follow up report will be submitted at the conclusion of the investigaiton.

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

Qn# (b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the filter was blocked.It was reported that "the filter is immediately blocked and the patient cannot be ventilated" during use.The returned device failed the drop test.This issue may happen due to the accumulation of condensation or secretions.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.Based on the investigation performed, the reported complaint of a blocked filer was confirmed.A root cause for the issue could not be determined.A conclusion code could not be found as the complaint was confirmed; however, a root cause was not established.

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: 7443212
• MDR Text Key: 106039982
• Report Number: 8040412-2018-00101
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1