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

Model Number IPN043782

Device Problem Obstruction of Flow (2423)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/07/2021

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).

Event 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".

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 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
• 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: 12733600
• MDR Text Key: 279941383
• Report Number: 8040412-2021-00269
• Device Sequence Number: 1
• Product Code: CAH
• UDI-Device Identifier: 04026704348664
• UDI-Public: 04026704348664
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964382
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• 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
• Date Manufacturer Received: 11/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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.
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention