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

Lot Number 414012

Device Problems Loose or Intermittent Connection (1371); Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 09/01/2021

Event Type  malfunction  

Event Description

When going to use needle device, the needle base dropped down and the needle kept pulling out, but the tip end mechanism never locked in place.

• Brand Name: DELTEC
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL MD, INC.; 6000 nathan ln n; minneapolis MN 55442
• MDR Report Key: 12459421
• MDR Text Key: 271020805
• Report Number: 12459421
• 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
• Type of Report: Initial
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 414012
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21170 DA