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

Model Number 306501

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem Blood Loss (2597)

Event Date 06/04/2019

Event Type  malfunction  

Event Description

Started iv using 18g angiocath, angiocath at the hub had a pinhole in it and blood was leaking out and when pushed saline flush, saline leaked out of pinhole.Iv had to be restarted, resulting a unnecessary stick.

• Brand Name: JELCO
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• MDR Report Key: 8739169
• MDR Text Key: 149345582
• Report Number: 8739169
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 06/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 306501
• Device Catalogue Number: 3065
• Device Lot Number: 3790614
• 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: 06/05/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28835 DA
• Patient Weight: 87