MAUDE Adverse Event Report: INTEGRA YORK, PA INC. JARIT DISPOSABLE FILTERS; N/A

Catalog Number 775200

Device Problem Failure to Align (2522)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A facility reported that the insertion of the hole in the jarit disposable filter (775200) was not in the center of the circle; it was misaligned when attached to the lid, and sterilization was incomplete.There was no patient injury and delay in surgery is unknown.

Manufacturer Narrative

The 775200 jarit disposable filters was returned for evaluation: failure analysis - the returned filters are in unused condition with the center pin hole off center due to alignment error.Root cause - the reported complaint is confirmed.The device is in used condition with the center pin hole off center due to alignment error.Inspection has been initiated for this issue.No further investigation required based on the acceptability of risk and no adverse trends identified.This will be monitored and trended going forward.

• Brand Name: JARIT DISPOSABLE FILTERS
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA YORK, PA INC.; 589 davies drive; 589 davies drive; york PA
• MDR Report Key: 12037189
• MDR Text Key: 260456255
• Report Number: 2523190-2021-00129
• Device Sequence Number: 1
• Product Code: KCT
• Combination Product (y/n): N
• PMA/PMN Number: K072563
• 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: 08/17/2021

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: Health Professional
• Device Catalogue Number: 775200
• Device Lot Number: 2002024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Initial Date Manufacturer Received: 05/24/2021
• Initial Date FDA Received: 06/21/2021
• Supplement Dates Manufacturer Received: 08/02/2021
• Supplement Dates FDA Received: 08/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1