MAUDE Adverse Event Report: RAYNHAM BULK SURG PAT 1/2 X 1/2; OEM PATTIES & STRIPS

Model Number	245404
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2022
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
It was reported the blue strip was separated from the neuro sponge inside the patient.The staff saw it before they closed up and had to irrigate the wound and scan for the sponges and any remaining pieces.No patient injury reported.
Additional Manufacturer Narrative
The surgical pattie was not returned for evaluation, however a photo was provided for evaluation: dhr review - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Failure analysis - the photo of the pattie/strip unit was inspected using the unaided eye.It was observed that the unit did in fact have an x-ray strip that was detached from the pattie.The complaint could be verified through failure analysis.Root cause - the complaint was confirmed in the complaint investigation.Although the complaint was confirmed, further investigation would need to be done with the physical unit to determine the root cause of the failure.Root cause could not be determined through just the photographic evidence.

• Brand Name: BULK SURG PAT 1/2 X 1/2
• Common Device Name: OEM PATTIES & STRIPS
• 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: 13484207
• Report Number: 3014334038-2022-00019
• Device Sequence Number: 17508465
• Product Code: HBA
• UDI-Device Identifier: 10381780513377
• UDI-Public: 10381780513377
• 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): 04/13/2022

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 Model Number: 245404
• Device Catalogue Number: 245404
• Device Lot Number: 5631032
• Was Device Available for Evaluation?: No
• 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: 03/30/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 04/13/2022
• Date Device Manufactured: 08/11/2021
• 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