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

Model Number	801407
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported a surgical pattie (id 801407) have a brown portion in cotton, discovered before the procedure.The product was in its sterile packaging and opened in the operating room.It was stored in the sterile supply room.The product was not in contact with the patient and patient was not prepped for surgery.No surgical delay was reported and the procedure was completed with a replacement product available.The patties were used for fess sinus surgery.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
The surgical patties (id 801407) were 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 - a photo was provided showing the brown spots on the cottonoid.The complaint could be verified through failure analysis.Root cause - the complaint was confirmed in the complaint investigation.Per the failure analyst: the ¿cottonoid material is formed from rayon.During processing, this rayon material is broken down into small, loose fibers.If the fibers do not break down properly, a small cluster of fibers can result.This creates a thick spot in the pattie.When the string or x-ray is ultrasonically welded on this spot it absorbs more energy than the rest of the pattie and results in a burn.Patties created on the hybrid machines are visually inspected during the operator before being carded.Operators fan through the stack of 10 patties counting each pattie and ensuring there are no defects.They then flip over the stack and repeat before attaching the stack to a card.Because the burn mark was missed the complaint can be attributed to operator error.Operators identified in the traveler will be retrained per an ils.¿ a corrective and preventative action (capa) a capa has been closed in (b)(6) 2022 for the patties/strips product family relate to discoloration, incorrect count, string issues, and x-ray detectability.The capa implemented preventative actions to minimize the issue reported.
Event or Problem Description
N/a.

• 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: 16894498
• Report Number: 3014334038-2023-00064
• Device Sequence Number: 20376812
• Product Code: HBA
• UDI-Device Identifier: 10381780515029
• UDI-Public: 10381780515029
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2023

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 Model Number: 801407
• Device Catalogue Number: 801407
• Device Lot Number: 6788555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2023
• Supplement Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 06/09/2023
• Date Device Manufactured: 01/12/2023
• 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