MAUDE Adverse Event Report: SMITH MEDICAL ASD, INC. JELCO; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number 408200

Device Problems Break (1069); Detachment Of Device Component (1104); Material Twisted/Bent (2981)

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

Event Date 12/27/2016

Event Type  malfunction  

Event Description

Patient was having iv site discontinued, intracath appeared to be twisted.When catheter untwisted, catheter broke leaving part of catheter in patient's vessel.Iv rn called bedside rn to bring tweezers, catheter pulled out.

• Brand Name: JELCO
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITH MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• MDR Report Key: 6266012
• MDR Text Key: 65355813
• Report Number: 6266012
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 408200
• Other Device ID Number: 16GX 2 IN
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2017
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR