MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC CARDINAL HEALTH ¿ CRANIOTOMY TRAY; NEUROLOGICAL TRAY

Model Number SNE13CRMG5

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2018

Event Type  malfunction  

Event Description

Operating room (or) circulating nurse opened 3-0 vicryl suture pop-offs that were in the craniotomy pack, and found an extra needle in it.It did not have any strands attached.Craniotomy pack catalog sne13crmg5 lot# 994263 exp.06/01/2020.Manufacturer response for neurological tray, cardinal health (per site reporter).Unknown.

• Brand Name: CARDINAL HEALTH ¿ CRANIOTOMY TRAY
• Type of Device: NEUROLOGICAL TRAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 8154677
• MDR Text Key: 130046232
• Report Number: 8154677
• Device Sequence Number: 1
• Product Code: OJG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: SNE13CRMG5
• Device Catalogue Number: SNE13CRMG5
• Device Lot Number: 994263
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21535 DA