MAUDE Adverse Event Report: RAYNHAM SURG PATXRAY 1/2X1/2-200; SURGICAL PATTIES

Model Number	801400
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The surgical patties (id 801400)  was not returned for evaluation after three good faith attempts (gfes) were made.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause of the reported issue could not be determined.However, a probable root cause for the reported complaint is improper x-ray weld.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.A corrective and preventive action (capa) was implemented preventative actions to minimize the issues for the patties/strips product family related to discoloration, incorrect count, string issues, and x-ray detectability.
Event or Problem Description
A facility reported the surgical patties (id 801400) did not show up on x-ray.They even tested outside of body on the field.No patient injury reported and the event did not led to surgical delay.

• Brand Name: SURG PATXRAY 1/2X1/2-200
• 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: 16019237
• Report Number: 3014334038-2022-00279
• Device Sequence Number: 12226976
• Product Code: HBA
• UDI-Device Identifier: 10381780514961
• UDI-Public: 10381780514961
• 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
• Report Date (Section B): 12/20/2022

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: 03/31/2026
• Device Model Number: 801400
• Device Catalogue Number: 801400
• Device Lot Number: 5372127
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2022
• Initial Report FDA Received Date: 12/20/2022
• Date Device Manufactured: 04/17/2021
• 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