MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUDSON ISO GARD FILTER; BREATHING CIRCUIT BACTERIAL FILTER

Model Number IPN043752

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 02/23/2022

Event Type  malfunction  

Event Description

It was reported "we use this lot of filter with our anesthesia respirators.Those filters often split in the middle.Clinical consequences: this cause leaks in the ventilation circuit and/or error messages during respirator tests".No patient involvement reported.

Manufacturer Narrative

(b)(4).

Event Description

It was reported "we use this lot of filter with our anesthesia respirators.Those filters often split in the middle.Clinical consequences: this cause leaks in the ventilation circuit and/or error messages during respirator tests".No patient involvement reported.

Manufacturer Narrative

(b)(4).The actual device along with representative samples were returned and sent to the manufacturing site for evaluation.The manufacturing site reports that one of the products was found to be detached.The complaint has been confirmed.The manufacturing site reports that the issue is supplier related and a non-conformance was opened to address the issue.

• Brand Name: HUDSON ISO GARD FILTER
• Type of Device: BREATHING CIRCUIT BACTERIAL FILTER
• 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: 13842070
• MDR Text Key: 287587273
• Report Number: 8040412-2022-00053
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN043752
• Device Catalogue Number: 19212T
• Device Lot Number: KMZ21E0420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: VENTILATOR; VENTILATOR