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

Model Number	80-1407
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Failure analysis - the surgical pattie was not yet returned for evaluation but a photo was provided: the pattie/strip unit was inspected using the unaided eye.A brown ¿spot¿ was found on the pattie around the area of the green string.The spot was produced when the x-ray and string were welded to the cottonoid material.The complaint could be verified through failure analysis.The complaint was confirmed in the complaint investigation.Per the failure analyst, the 801407 patties are produced on automated machines.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.There is currently an open corrective action to investigate the patties/strips product family.
Event or Problem Description
A facility reported yellow stains in surgical patties ((b)(4)) when the scrub nurse opened the package during the surgery preparation.The product was stored in a 24 hours temperature controlled goods located on shelf in a medical consumable store in hospital.No patient contact/injury reported and the event did not led to surgical delay.

• Brand Name: SURG PAT XRAY 1/2X3 -200
• Common Device Name: SURGICAL PATTIES
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13636060
• Report Number: 3014334038-2022-00036
• Device Sequence Number: 2124614
• Product Code: HBA
• UDI-Device Identifier: 20886704036545
• UDI-Public: 20886704036545
• Combination Product (Y/N): N
• PMA/510(K) Number: K880402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 80-1407
• Device Catalogue Number: 801407
• Device Lot Number: HX1393
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 03/01/2022
• Date Device Manufactured: 06/23/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown