MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. TRACH-VENT+STERILE; CONDENSER, HEAT AND MOISTURE

Catalog Number 41311U

Device Problem Break (1069)

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

Event Date 08/09/2023

Event Type  malfunction  

Event Description

It was reported that "the nurse found connector broken when using on patient, no impact on patient".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).There was no sample returned for this complaint.Therefore, we are not able to identify the location of "connector broken" as per reported.In the current manufacturing procedure, 100% visual inspection is conducted at assembly area.Thus, any ineffective products will be culled out during this process.Therefore, it is very unlikely condition at the manufacturing area that the product having defect to be released for shipment.A device history record review was performed, and no relevant findings were identified.In the absence of returned sample and limited information available on this complaint, further investigation could not be conducted and therefore the complaint is not confirmed.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that "the nurse found connector broken when using on patient, no impact on patient".At the time of this report the customer has not returned our requests for additional information.If additional information is received, the complaint file will be updated.

• Brand Name: TRACH-VENT+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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17712860
• MDR Text Key: 322989148
• Report Number: 8040412-2023-00341
• 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: 08/24/2023

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: 41311U
• Device Lot Number: KMH22A0048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 10/03/2023
• Supplement Dates FDA Received: 10/19/2023
• 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