MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HCH ASSY,AQUA+ TS; CONDENSER, HEAT AND MOISTURE (

Catalog Number 1574

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that a hair was found in the package upon opening.Therefore, a new unit was used instead.No patient involvement.

Manufacturer Narrative

Qn# (b)(4).Customer complaint cannot be confirmed as no product sample was available to perform a proper investigation and determine the root c ause.There was no sample returned for this complaint.Therefore, a product from a previous complaint was reviewed.No foreign matter found inside the pouches for these samples.In current manufacturing procedure, 100% visual inspection after assembly process is conducted.Thus, any defective products will be culled out during this process.Therefore, it is very unlikely condition at the manuf acturing area that the product having abnormality to be released for shipment.If the alleged defect samples become available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that a hair was found in the package upon opening.Therefore, a new unit was used instead.No patient involvement.

• Brand Name: HCH ASSY,AQUA+ TS
• Type of Device: CONDENSER, HEAT AND MOISTURE (
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL SDN. BHD.; lot no : pt2577 jalen perusahaan; 4 kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17543588
• MDR Text Key: 321276466
• Report Number: 8040412-2023-00322
• Device Sequence Number: 1
• Product Code: BYD
• UDI-Device Identifier: 04026704399086
• UDI-Public: 04026704399086
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1574
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/15/2023
• 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
• Treatment: N/A.; N/A.