MAUDE Adverse Event Report: SMITH MEDICAL ABD, INC. PROTECTIV PLUS SAFETY I.V. CATHETER; IV CATH-20GA X 1 1/4

Lot Number ST2980443

Device Problems Kinked (1339); Occlusion Within Device (1423); Device Displays Incorrect Message (2591)

Patient Problem Obstruction/Occlusion (2422)

Event Date 01/05/2016

Event Type  malfunction  

Event Description

A (b)(6) iv was placed in the left ac.Blood products were running without difficulty.Pt bent his arm a few times which created an occlusion error on the pump.After the third time, flushed cath without diff but pump cont to alarm.Cath was removed and was severely kinked that was under the skin and would not unkink.

• Brand Name: PROTECTIV PLUS SAFETY I.V. CATHETER
• Type of Device: IV CATH-20GA X 1 1/4
• Manufacturer (Section D): SMITH MEDICAL ABD, INC.; southington CT 06489
• MDR Report Key: 5412393
• MDR Text Key: 37620065
• Report Number: MW5060015
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/02/2016

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 Operator: Health Professional
• Device Expiration Date: 05/01/2018
• Device Lot Number: ST2980443
• Other Device ID Number: REF 3066
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/02/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 55 YR