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

Model Number	245404
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported the blue strip came off a surgical pattie (id 245404).The event happened during procedure, no patient injury reported and the event did not led to surgical delay.
Additional Manufacturer Narrative
Complaint sample was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and manufacturing records could not be reviewed.The cause(s) of the difficulty reported by the customer 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.

• 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: 16401637
• Report Number: 3014334038-2023-00018
• Device Sequence Number: 5705743
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/17/2023

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: 245404
• Device Catalogue Number: 245404
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2022
• Initial Report FDA Received Date: 02/20/2023
• 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