MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUMID-VENT FILTER COMPACT STR STERILE; CONDENSER, HEAT AND MOISTURE

Catalog Number G19401

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 02/08/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "the package was found torn when the unit was taken out of the box".No patient involvement reported.

Manufacturer Narrative

Qn# (b)(4).The sample was returned for evaluation.A visual exam was performed and it was found that the packaging was torn.A device history record review was performed and no relevant findings were identified.Based on the visual exam of the returned sample, the complaint was confirmed.The paper of the package was found torn before use.This may happen due to mishandling during the packing process.The manufacturing site reports that in the current manufacturing procedure, 100% light inspection is done during the packing process.Operators who conduct the inspection, will reject the product if there is any torn packaging.However, it is suspected that the package was torn off after visual inspection during packing the product into cartons.A non-conformance was opened to address this issue.

Event Description

It was reported that "the package was found torn when the unit was taken out of the box".No patient involvement reported.

Manufacturer Narrative

Qn#: (b)(4).A second investigation was performed and the updated results are as follows: the sample was returned for evaluation.A visual exam was performed and it was found that the packaging was torn.A device history record review was performed and no relevant findings were identified.Based on the visual exam of the returned sample, the complaint was confirmed.The paper of the package was found to be torn.This may happen due to mishandling of the product.The manufacturing site reports that in the current manufacturing procedure, 100% light inspection is done during the packing process.Operators who conduct the inspection, will reject the product if there is any torn packaging.Although the complaint was confirmed, a true root cause for the issue could not be identified.

Event Description

It was reported that "the package was found torn when the unit was taken out of the box." no patient involvement reported.

• Brand Name: HUMID-VENT FILTER COMPACT STR STERILE
• Type of Device: CONDENSER, HEAT AND MOISTURE
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11399992
• MDR Text Key: 244398288
• Report Number: 8040412-2021-00042
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2021

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 Operator: No Information
• Device Catalogue Number: G19401
• Device Lot Number: 19KT61J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Manufacturer Received: 02/09/2021
• Initial Date FDA Received: 03/02/2021
• Supplement Dates Manufacturer Received: 03/31/2021; 03/31/2021
• Supplement Dates FDA Received: 03/31/2021; 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.; N/A.