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

Catalog Number G19501

Device Problem No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Complaint reported as: it was reported that the user found it difficult to remove the luer cap as it was too tight.Also, when the filter was connected to the co2 monitor, nothing was displayed on the monitor.Therefore, the user replaced the filter with a new one, by which the monitor displayed normally.No patient harm reported.

Manufacturer Narrative

Qn# (b)(4).The sample was returned to the manufacturing site for evaluation.The manufacturing site reports a visual exam was performed and no issues were observed.It was also reported that based on clinician review it was determined there are many possible reasons as to why the user would not be able to get a co2 reading.The most important reason is that there is no co2 in the respired gases (for example the gas pathway is not in communication with the patient such as occurs with esophageal intubation).It is suspected that this complaint is due to the method of usage at the customer end, although this could not be confirmed.

Event Description

Complaint reported as: it was reported that the user found it difficult to remove the luer cap as it was too tight.Also, when the filter was connected to the co2 monitor, nothing was displayed on the monitor.Therefore, the user replaced the filter with a new one, by which the monitor displayed normally.No patient harm reported.

• 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
• MDR Report Key: 10364404
• MDR Text Key: 201604300
• Report Number: 8040412-2020-00161
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

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: No Information
• Device Catalogue Number: G19501
• Device Lot Number: 19KT40J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Initial Date Manufacturer Received: 07/22/2020
• Initial Date FDA Received: 08/04/2020
• Supplement Dates Manufacturer Received: 09/21/2020
• Supplement Dates FDA Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.