MAUDE Adverse Event Report: XOMED MFG MYSTIC NEURAY® PACKING; NEUROSURGICAL PADDIE

Model Number	8004000
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) reported that on a arthroplasty.A device's patties were coming off of the strings.There was no patient impact.Upon follow up it was confirmed that patties were used on a patient during an arthroplasty.It was during the procedure when the rn identified that the patties were coming off of the strings.Here was no impact to patient or staff because this problem was identified during the procedure.His product was discarded during the case due to it being contaminated with blood.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The event was reported to medwatch but the report number was unknown.There was no delay in the surgical procedure.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The remaining patties off of the shelf were pulled.

• Brand Name: NEURAY® PACKING
• Common Device Name: NEUROSURGICAL PADDIE
• Manufacturer (Section D): XOMED MFG MYSTIC; 950 flanders rd; mystic CT 06355
• MDR Report Key: 9568144
• Report Number: 1219071-2020-00001
• Device Sequence Number: 19539263
• Product Code: HBA
• UDI-Device Identifier: 00643169931985
• UDI-Public: 00643169931985
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K923027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2020

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: 10/01/2022
• Device Model Number: 8004000
• Device Catalogue Number: 8004000
• Device Lot Number: 00030431
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2019
• Supplement Date Received by Manufacturer: 01/09/2020; 02/04/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 01/13/2020; 02/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1