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

Model Number	24-5404
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The surgical patty (id 245404) is not available for return (discarded) as per customer; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.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.There is currently an open corrective and preventative action (capa) to investigate product issues related to missing x-ray material on surgical patties.
Event or Problem Description
A facility reported a surgical pattie (id 245404) was noted to be missing the blue strip and was unable to be found.After getting all 10 patties off the field, one pattie was noted to be missing the blue strip and was unable to be found.The event did not lead to surgical delay.

• 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: 17097969
• Report Number: 3014334038-2023-00079
• Device Sequence Number: 7663055
• Product Code: HBA
• UDI-Device Identifier: 20886704004131
• UDI-Public: 20886704004131
• 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): 06/09/2023

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: 24-5404
• Device Catalogue Number: 245404
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 06/09/2023
• Date Device Manufactured: 08/12/2019
• 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