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

Model Number	801400
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
A facility reported a small orange foreign object within the packaging of a surgical pattie (id 801400).The issue was detected during pre-surgery and no patient injury was reported.
Additional Manufacturer Narrative
The surgical pattie (id: 801400) 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: complaint sample reviewed and confirmed, foreign material present in sealed package.Operators are trained to inspect packages to ensure they are free of debris.Per procedure, "there shall be no loose particles or foreign matter in the flexible blister larger than.80 sq mm in any dimension and there shall be no more than five particles.25 sq mm or larger, measured with the transparent chart for estimation of defect size.Root cause: the complaint was confirmed in the complaint investigation.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.The root cause is operator error.
Event or Problem Description
N/a.

• 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: 16684696
• Report Number: 3014334038-2023-00046
• Device Sequence Number: 8116046
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2023

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: 801400
• Device Catalogue Number: 801400
• Device Lot Number: 6396472
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2022
• 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