MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. H-V FILTER SMALL STRAIGHT, STERILE; CONDENSER, HEAT AND MOISTURE

Catalog Number G19501

Device Problem Unsealed Device Packaging (1444)

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

Event Date 05/25/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that, "when checking the filter before use, the package was not sealed completely; the sealed part was slightly open.Therefore, a new unit was used instead".No patient involvement.

Manufacturer Narrative

Qn#(b)(4).The sample was returned and sent to the manufacturing site for evaluation.The manufacturing site reports that a visual exam was per formed and it was observed that the seal was slightly open.It was also reported that "in current manufacturing procedure, 100% visual inspection after packing process is conducted.Thus, any ineffective products will be culled out during this process.Therefore, it is very unlikely condition at the manufacturing area that the defect product to be released for shipment." a device history record review was performed and no relevant findings were identified.The complaint was confirmed; however, a root cause for the issue could not be identified.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that, "when checking the filter before use, the package was not sealed completely; the sealed part was slightly open.Therefore, a new unit was used instead".No patient involvement.

• Brand Name: H-V FILTER SMALL STRAIGHT, STERILE
• 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: 17138874
• MDR Text Key: 317331106
• Report Number: 8040412-2023-00265
• Device Sequence Number: 1
• Product Code: BYD
• 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: 05/29/2023

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: G19501
• Device Lot Number: KMH22J0165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/29/2023
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: 07/18/2023
• Supplement Dates FDA Received: 07/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• 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