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

Model Number	801400
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2022
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 the white cloth attached to green string of the surgical pattie is staying in the patient.No patient injury reported.No additional information was provided after several attempts.
Additional Manufacturer Narrative
The surg patxray (id 801400) was returned for evaluation.Based on the dhr review conducted, there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.The pattie/strip unit was inspected using the unaided eye.Samples taken from the 48 returned cards, and delamination was confirmed to be occurring in the samples.The complaint could be verified through failure analysis.Per the complaint background, pattie delamination.The root cause is undetermined and was unable to be confirmed in the complaint evaluation.A device history record (dhr) review and trending were performed as part of the evaluation.Proper finished goods testing was performed prior to release as indicated in the dhr.Product was received for analysis, and the investigation could confirm the complaint.The risk remains acceptable per the risk analysis.A corrective and preventive action (capa) has been opened for this product issue and any actions will be captured under the capa.
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: 13484267
• Report Number: 3014334038-2022-00020
• Device Sequence Number: 12109391
• 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): 08/02/2022

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: 06/30/2026
• Device Model Number: 801400
• Device Catalogue Number: 801400
• Device Lot Number: 5542732
• 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: 01/21/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 08/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2021
• 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