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

Model Number 8004000

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/19/2019

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The event was reported to medwatch but the report number was unknown.There was no delay in the surgical procedure.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

The remaining patties off of the shelf were pulled.

• Brand Name: NEURAY® PACKING
• Type of Device: NEUROSURGICAL PADDIE
• Manufacturer (Section D): XOMED MFG MYSTIC; 950 flanders rd; mystic CT 06355
• Manufacturer (Section G): XOMED MFG MYSTIC; 950 flanders rd; mystic CT 06355
• Manufacturer Contact: christy cain ; 6743 southpoint drive north; jacksonville, FL 32216 ; 9043328353
• MDR Report Key: 9568144
• MDR Text Key: 179259474
• Report Number: 1219071-2020-00001
• Device Sequence Number: 1
• Product Code: HBA
• UDI-Device Identifier: 00643169931985
• UDI-Public: 00643169931985
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/04/2020
• Date Device Manufactured: 10/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1