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

Model Number	IPN043751
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 8040412-2022-00319
• Device Sequence Number: 6156861
• Product Code: CAH
• UDI-Device Identifier: 04026704348008
• UDI-Public: 04026704348008
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2022
• Supplement Date Received by Manufacturer: 12/22/2022
• Initial Report FDA Received Date: 11/18/2022
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown