MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. GIBECK HUMID-VENT FILTER SMALL STRAIGHT; FILTER, BACTERIAL, BREATHING-C

Model Number	IPN043782
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	10/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported "decreased tidal volume with use of the hme.Therapy was delayed/interrupted, and medical intervention was necessary.Patient desatted < 88%.The hme had to be changed out to a different kind".Patient condition reported as "stable".
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not returned for evaluation.The manufacturing site reports "patients not getting volumes was highly suspected due to the leakage in the device or connection of the device.However since there was no device return the root cause of this defect could not be determined.In current manufacturing procedure, 100% leak testing and visual inspection after assembly process are conducted.Thus, any ineffective products will be culled out during this process.Therefore, it is very unlikely condition at the manufacturing area that the leak product to be released for shipment.There was no change of material for the product since it was introduced to the market.".
Event or Problem Description
It was reported "decreased tidal volume with use of the hme.Therapy was delayed/interrupted, and medical intervention was necessary.Patient desatted (b)(4).The hme had to be changed out to a different kind".Patient condition reported as "stable".

• Brand Name: GIBECK HUMID-VENT FILTER SMALL STRAIGHT
• 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: 12733600
• Report Number: 8040412-2021-00269
• Device Sequence Number: 16513959
• Product Code: CAH
• UDI-Device Identifier: 04026704348664
• UDI-Public: 04026704348664
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K964382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN043782
• Device Catalogue Number: 19502
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 11/26/2021
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: VENTILATOR.; VENTILATOR.
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Unknown