MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. H-V FILTER SMALL STRAIGHT, STERILE; CONDENSER, HEAT AND MOISTURE

Catalog Number G19501

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

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

Event Date 04/26/2021

Event Type  malfunction  

Manufacturer Narrative

Qn(b)(4).

Event Description

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

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the packaging was torn.A device history record review was performed and no relevant findings were identified.Based on the visual exam, the reported complaint was confirmed.In the current manufacturing procedure, a 100% visual inspection is conducted at the packing area.Any defective products would be detected prior to release from the manufacturing facility.The ifu states not to use if the package is broken and storage instructions mention not to use if the product sterilization barrier or packaging is compromised.Although the complaint was confirmed, a root cause could not be established.It is most likely that the issue occurred due to mishandling of the product; however, this could not be confirmed.

Event Description

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

• Brand Name: H-V FILTER SMALL STRAIGHT, STERILE
• Type of Device: CONDENSER, HEAT AND MOISTURE
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11836390
• MDR Text Key: 264742067
• Report Number: 8040412-2021-00134
• 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
• Report Date: 04/26/2021

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: G19501
• Device Lot Number: KMH20K0460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2021
• Initial Date Manufacturer Received: 04/26/2021
• Initial Date FDA Received: 05/17/2021
• Supplement Dates Manufacturer Received: 06/14/2021
• Supplement Dates FDA Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1