MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUDSON ISO GARD FILTER; BREATHING CIRCUIT BACTERIAL FILTER

Model Number IPN043752

Device Problems Material Separation (1562); Material Split, Cut or Torn (4008)

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

Event Date 01/10/2022

Event Type  malfunction  

Event Description

It was reported that "several times, when removing the respirator tube, the filter splits and brakes".The filters were replaced.No injury or harm reported.Patient condition reported as "fine".

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that "several times, when removing the respirator tube, the filter splits and brakes".The filters were replaced.No injury or harm reported.Patient condition reported as "fine".

Manufacturer Narrative

(b)(6).The sample was returned for evaluation.A visual exam was performed and it was observed that an incomplete device was returned.A device history record review was performed and no relevant findings were identified.The manufacturing site reports that in the current manufacturing procedure, 100% leak testing during the assembly process and 100% visual inspection at the packing area is conducted, thus any defective product would be detected prior to release from the manufacturing facility.The detachment of the product could be due to high force applied on the device, or mishandling of the device by the user.The complaint of detachment was confirmed; however, a root cause for the issue could not be identified.It is possible the issue is user related, however, this could not be confirmed.

• Brand Name: HUDSON ISO GARD FILTER
• Type of Device: BREATHING CIRCUIT BACTERIAL FILTER
• 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: 13514912
• MDR Text Key: 285479306
• Report Number: 8040412-2022-00034
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 01/20/2022

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: IPN043752
• Device Catalogue Number: 19212T
• Device Lot Number: KMZ21J0403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 02/11/2022
• Supplement Dates Manufacturer Received: 03/10/2022
• Supplement Dates FDA Received: 03/10/2022
• 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