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

Model Number 21-2762-24

Device Problems Moisture Damage (1405); Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 12/02/2021

Event Type  malfunction  

Event Description

Moisture/bubbling contaminant discovered inside of port access tubing.

• Brand Name: DELTEC GRIPPER PLUS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL MD, INC.; 6000 nathan ln n; minneapolis MN 55442
• MDR Report Key: 12967406
• MDR Text Key: 281986955
• Report Number: 12967406
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 21-2762-24
• Device Catalogue Number: 21-2762-24
• Device Lot Number: 4142802
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1