MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUDSON HUMID VENT COMPACT S; FILTER, BACTERIAL, BREATHING CIRCUIT

Model Number IPN043766

Device Problem Material Fragmentation (1261)

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

Event Date 04/28/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported that "white filter material trickles out of the filter".No patient injury or harm reported.Patient condition reported as "fine".

Event Description

It was reported that "white filter material trickles out of the filter".No patient injury or harm reported.Patient condition reported as fine.

Manufacturer Narrative

(b)(4), the customer returned the actual sample along with three representative samples.The manufacturing site has reported "from the investigation conducted on the actual samples, the complaint on white filter material was not confirmed.The defect was found after 5 to 7 hours usage time.Ifu mention that replace unit immediately if soiled with secretion or otherwise obstructed.Humid-vent is designed for single use only and should not be cleaned and re-used.In current manufacturing procedure, 100% visual inspection after assembly process is conducted.Thus, any ineffective products will be culled out during this process.Therefore, it is very unlikely condition at the manufacturing area that the product having white filter material be released for shipment.There is no similar defect observed at manufacturing site." a device history record review was performed and no relevant findings were identified.The root cause is listed as user related.

• Brand Name: HUDSON HUMID VENT COMPACT S
• Type of Device: FILTER, BACTERIAL, BREATHING CIRCUIT
• 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 ; 9193614124
• MDR Report Key: 14514365
• MDR Text Key: 292729237
• Report Number: 8040412-2022-00120
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/28/2022

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
• Device Model Number: IPN043766
• Device Catalogue Number: 19401
• Device Lot Number: KMH20J0172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/26/2022
• Supplement Dates Manufacturer Received: 06/16/2022
• Supplement Dates FDA Received: 06/21/2022
• 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