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

Model Number	801400
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported a possible oil stain or sealant damage on a surgical pattie package seal (id (b)(4)).Issue detected by the distributor: "all the seals have this oil like substance, only on the seals.When lifting up in the light, it has a see-through effect.".
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 patty (id: 801400)  was 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: the photo shows the overheated area on the packaging, therefore, the complaint can be confirmed.It is noted that without the product return, it can only be visually confirmed that there was over heating of the seal, and that without the physical product it is not possible to test the seal strength to ensure it is a complete seal.The complaint is still confirmed.Root cause: the complaint was confirmed in the complaint investigation through photograph provided by the customer.Potential root causes include incorrect fluctuating seal parameters, thin tyvek, malfunction heating element or broken element wire, or damaged thermocouple.
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: 16766030
• Report Number: 3014334038-2023-00052
• Device Sequence Number: 12260165
• 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): 07/20/2023

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: 6829676
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 07/11/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 07/20/2023
• Date Device Manufactured: 02/14/2023
• 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