MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUMID VENT FILTER COMPACT WITH HME; FILTER, BACTERIAL, BREATHING-C

Model Number IPN043770

Device Problem Particulates (1451)

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

Event Date 08/11/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "while draeger anesthetic device was undergoing 6-year ppm service, fibers were detected within the breathing system on the expiration side.Medical physics inspected all perseus breathing systems and found small amounts of fibers trapped in the expiration limb.All teleflex hme filters were removed and replaced with teleflex bacteria iso flex filters until a replacement filter is sourced".No patient involvement.

Manufacturer Narrative

(b)(4).No complaint product was returned for investigation.However, customer has provided the sample of foreign matter.Complaint reported that filters are leaving fibers in their breathing circuit.Sample foreign matter fiber has returned for investigation without the actual complaint product.The complaint on foreign matter was not confirmed.There is no similar material like fiber use as the component of the assembled product.Furthermore, complaint reported that fibers were detected within the breathing system on the expiration side, and it may not cause from the product itself.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 foreign matter to be released for shipment.Visual inspection of any foreign matter will be culled out during inspection.The foreign matter may be caused from contamination during handling process.Therefore, this complaint could not be confirmed.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that "while draeger anesthetic device was undergoing 6-year ppm service, fibers were detected within the breathing system on the expiration side.Medical physics inspected all perseus breathing systems and found small amounts of fibers trapped in the expiration limb.All teleflex hme filters were removed and replaced with teleflex bacteria iso flex filters until a replacement filter is sourced".No patient involvement.

• Brand Name: HUMID VENT FILTER COMPACT WITH HME
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17642601
• MDR Text Key: 322183616
• Report Number: 8040412-2023-00332
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN043770
• Device Catalogue Number: 19402T
• Device Lot Number: KMZ22F0786
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1