MAUDE Adverse Event Report: NOVO HEALTH SERVICES FIBER MEDICAL ABSORBENT; TOWEL

Model Number	KIT 2314 PRODUCT 2000
Medical Device Problem Codes	Device Reprocessing Problem (1091); Contamination /Decontamination Problem (2895); Failure to Clean Adequately (4048)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Missing Value Reason (3192)
Date of Event	10/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred with the patient under anesthesia.There is no known impact on the patient.The surgical case was broke down and reopened due to the fiber raytex "falling out" of the medical absorbent towel.The product was not returned to the facility for evaluation.Novo health services quality manager conducted awareness training of the event, and in-service training with the facility on proper sorting during the soiled process and proper inspection process.
Event or Problem Description
The user facility reported that while the surgical technician and the doctor were draping the patient with reusable sterile towels a raytex fell out of the towel and landed on the patient.The raytex count was preformed to verify that the sponge was "extra.".

• Brand Name: FIBER MEDICAL ABSORBENT
• Common Device Name: TOWEL
• Manufacturer (Section D): NOVO HEALTH SERVICES; 7086 industrial row drive; mason OH 45040
• MDR Report Key: 9244413
• Report Number: 1000306225-2019-00003
• Device Sequence Number: 11216202
• Product Code: FRL
• UDI-Device Identifier: 00812564036889
• UDI-Public: 00812564036889
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: KIT 2314 PRODUCT 2000
• Device Catalogue Number: KIT 2314 PRODUCT 2000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other