MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. GIBECK ISO-GARD FILTER S; FILTER, BACTERIAL, BREATHING-C

Model Number IPN043751

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 11/01/2022

Event Type  malfunction  

Event Description

It was reported that "the hme filters iso-gard filter s suddenly split during operation".Further information states that "the filters were in use only a few hours each time.In no case was there a drop in oxygen saturation or damage to the patient".See associated mdrs 8040412-2022-00316 and 8040412-2022-00318.

Manufacturer Narrative

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

Manufacturer Narrative

Qn# (b)(4).The actual sample was not returned; however, the customer provided a photo for evaluation.A visual exam was performed on the photo and it was observed that the filter was detached.Based on the photo, the complaint was confirmed.The manufacturer reports that the housing of the device is from a supplier.A device history record review was performed and it was found that the affected lot (kmz21k0046) is under the scope of a product recall.A capa has been opened to address this issue.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that "the hme filters iso-gard filter s suddenly split during operation".Further information states that "the filters were in use only a few hours each time.In no case was there a drop in oxygen saturation or damaged to the patient".See associated mdrs 8040412-2022-00316 and 8040412-2022-00318.

• Brand Name: GIBECK ISO-GARD FILTER S
• Type of Device: FILTER, BACTERIAL, BREATHING-C
• 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: 15825962
• MDR Text Key: 304217105
• Report Number: 8040412-2022-00319
• Device Sequence Number: 1
• Product Code: CAH
• UDI-Device Identifier: 04026704348008
• UDI-Public: 04026704348008
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN043751
• Device Catalogue Number: 19212
• Device Lot Number: KMZ21K0046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2021
• 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