MAUDE Adverse Event Report: RAYNHAM BULK SURG PAT 1/2 X 3; OEM PATTIES & STRIPS

Catalog Number 245411

Device Problem Contamination (1120)

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

Event Date 08/04/2021

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

The facility reported stained surgical patties.The or staff had to break down another craniotomy set up due to stained patties.The case was delayed for 20 minutes until the instruments were reprocessed.

Event Description

N/a.

Manufacturer Narrative

The surgical pattie was not returned for evaluation but a photo was provided: device history record (dhr): there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis: the pattie/strip photo was inspected using the unaided eye.Complaint of burn around area of the green string was confirmed.The complaint could be verified through failure analysis.The cottonoid is formed from a rayon material.During processing, rayon material is broken down into small fibers.If the fibers are not properly broken down, a small cluster of fibers can result.This creates a thick spot in the pattie.When the string is ultrasonically welded on this spot it absorbs more energy than the rest of the pattie and results in a burn.Automated machines are used to produce 245411 patties.The patties are inspected by a computer vision inspection system that inspects the patties for defects.The burn marks are difficult to detect due to the type of color filters used on the camera lens.A corrective action was initiated to further investigate the failure.

• Brand Name: BULK SURG PAT 1/2 X 3
• Type of Device: OEM PATTIES & STRIPS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• MDR Report Key: 12351278
• MDR Text Key: 267672104
• Report Number: 3014334038-2021-00173
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• PMA/PMN Number: K880402
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor
• Type of Report: Initial,Followup
• Report Date: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 245411
• Device Lot Number: J86T82
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1