MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUMID VENT COMPACT S; CONDENSER, HEAT AND MOISTURE

Catalog Number 19401

Device Problem Break (1069)

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

Event Date 06/26/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "the doctor found sterile package damage when doing clinical setting before using on patient.Then changed new one, no impact on patient." no patient involvement.

Event Description

It was reported that "the doctor found sterile package damage when doing clinical setting before using on patient.Then changed new one, no impact on patient." no patient involvement.

Manufacturer Narrative

(b)(4), the actual device was returned and sent to the manufacturing site for investigation.The manufacturing site reports "based on the investigation conducted on the returned sample, the paper of the package was found torn before use.Complaint was confirmed as reported.However complaint could not be verified as manufacturing related issue.This packaging torn may happen due to mishandling of the product.In current manufacturing procedure, 100% visual inspection is done at the packing area.Thus, any torn pouch product noticed will be culled out during this process.Ifu state that do not use if package is broken, and storage instruction mention that do not use if the product sterilization barrier or its packaging is compromised.In current manufacturing procedure, 100% light inspection is done during packing process.Operator who conduct the inspection will reject the product if there is any torn package.There is very unlikely for the torn package product will be released for shipment.No abnormality found during the packing process of this product.There is no mishandling issue during the packing process.Lrr (lot rejection rate) record shows there is no similar defect for this product found during qa buy off.".

• Brand Name: HUMID VENT COMPACT S
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17341973
• MDR Text Key: 319197980
• Report Number: 8040412-2023-00291
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/26/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 19401
• Device Lot Number: KMH22E0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/18/2023
• Supplement Dates Manufacturer Received: 08/15/2023
• Supplement Dates FDA Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2022
• 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