MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; NEURO SPONGE IN DBD-FORAMENOTOMY PACK

Catalog Number DYNJ903630

Device Problems Component Falling (1105); Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

It was reported a neuro sponge shredded during use and fibers fell in to the surgical site.The fibers were easily identified by the surgeon and removed by flushing and suctioning the surgical site.No delay occurred in the procedure and the patient remained stable.The procedure continued without further incident.An unused single sterile package was returned and not the component from the surgical pack.A sample was pulled from stock and also investigated along with the returned sample.The reported incident could not be confirmed and a root cause cannot be determined.Due to the reported incident and in an abundance of caution this medwatch is being filed.

Event Description

It was reported a neuro sponge shredded and fell into the surgical site.

• Type of Device: NEURO SPONGE IN DBD-FORAMENOTOMY PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: megan debus ; three lakes drive; northfield, IL 60093 ; 8477703962
• MDR Report Key: 6499783
• MDR Text Key: 73021122
• Report Number: 1423395-2017-00012
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Catalogue Number: DYNJ903630
• Device Lot Number: 16UB7316
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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
• Patient Outcome(s): Other