MAUDE Adverse Event Report: RAYNHAM SURG PAT XRAY 1/2X3 -200; SURGICAL PATTIES

Catalog Number 801407

Device Problem Contamination (1120)

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

Event Date 07/30/2021

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

A facility reported a surgical pattie with "dirty material".No patient contact/injury reported and the event did not led to surgical delay.The product was stored inside the pharmacy storeroom.

Manufacturer Narrative

The surgical patties was returned for evaluation.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 - product was returned for failure analysis, and the following was performed on the returned unit: the pattie/strip unit was inspected using the unaided eye.The brown spot on the pattie was confirmed.The complaint could be verified through failure analysis.Per the failure analyst: ¿a brown 'spot' was found on a pattie sample around the area of the green string and x-ray.The spot was produced when the x-ray and string were welded to the cottonoid material.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 801407 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.¿ currently the complaint issue does not represent an adverse trend, however the issue will continue to be monitored and trended through the complaint evaluation process.The risk remains acceptable per the risk analysis.A corrective action was created to investigate this issue.

Event Description

N/a.

• Brand Name: SURG PAT XRAY 1/2X3 -200
• Type of Device: SURGICAL PATTIES
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• MDR Report Key: 12375544
• MDR Text Key: 268460094
• Report Number: 3014334038-2021-00176
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 801407
• Device Lot Number: J9004P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2021
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1