MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC.; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 4194288

Device Problems Component Missing (2306); Material Twisted/Bent (2981)

Patient Problem Insufficient Information (4580)

Event Date 11/03/2021

Event Type  malfunction  

Event Description

18 gauge needle found in supply cart bent and without plastic cover over needle still intact in package.

• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan ln n; minneapolis MN 55442
• MDR Report Key: 12877754
• MDR Text Key: 281275526
• Report Number: 12877754
• Device Sequence Number: 1
• Product Code: FPA
• 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: 11/18/2021

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
• Device Lot Number: 4194288
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/26/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1