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

Model Number 308700

Device Problem Detachment Of Device Component (1104)

Patient Problem Blood Loss (2597)

Event Date 07/25/2017

Event Type  malfunction  

Event Description

Started iv in usual pattern using 20 gauge angio.Obtained blood return and advanced catheter until it clicked.Retracted needle without loosening connection or detaching angio from hub.Applied tegaderm and then angio detached from hub.Blood started to run down the hand.Immediately applied digital pressure to minimize blood loss.Proceeded to connect iv tubing to hub, taped tubing to hand and then wiped off blood.The 20g angio lot# 3417461.

• Brand Name: JELCO
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 1265 grey fox rd.; saint paul MN 55112
• MDR Report Key: 6773193
• MDR Text Key: 82029145
• Report Number: 6773193
• 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: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 308700
• Device Lot Number: 3417461
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/03/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Age: 46 YR