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

Catalog Number	1574
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that a hair was found in the package upon opening.Therefore, a new unit was used instead.No patient involvement.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 8040412-2023-00322
• Device Sequence Number: 6369759
• Product Code: BYD
• UDI-Device Identifier: 04026704399086
• UDI-Public: 04026704399086
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 1574
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 09/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown