MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUDSON H-V FILTER COMP/EXPANDI-FLEX,STER-CNPH; HUMID-VENT FILTER

Catalog Number G19621C

Device Problem Connection Problem (2900)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/26/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported at the "upper part where the filter is presented, the product is detaching" during use.Additional information was not available at the time of this report.

Event Description

Customer reported at the "upper part where the filter is presented, the product is detaching" during use.Additional information was not available at the time of this report.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed it was observed that the product was detached.Ten pieces of the same catalog number were taken from production at the manufacturing facility and inspected for the reported defect.No defects were identified.In addition, all ten pieces passed leak testing and pull testing.A device history record review was performed and no relevant findings were identified.Based on the visual exam of the returned product, the reported complaint was confirmed.Improper assembly of the product can be the reason why the product can be easily detached.Improper assembly can also make the product fail the leak test.In the current manufacturing procedure, 100% leak testing during the assembly process and 100% visual testing at the packing area is conducted; thus, any defective product will be detected prior to release from the manufacturing facility.It is very likely the detachment was caused by mishandling of the product during usage; although, this could not be confirmed.

• Brand Name: HUDSON H-V FILTER COMP/EXPANDI-FLEX,STER-CNPH
• Type of Device: HUMID-VENT FILTER
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 9273565
• MDR Text Key: 183740817
• Report Number: 8040412-2019-00309
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/28/2023
• Device Catalogue Number: G19621C
• Device Lot Number: 18ET32
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.