MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INTROCAN SAFETY® 3; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 4251129-02

Device Problems Failure to Prime (1492); Physical Resistance (2578)

Patient Problem No Information (3190)

Event Date 02/05/2018

Event Type  malfunction  

Event Description

Iv established to right forearm, good blood return.Iv initially flushed easily and then met resistance, unable to flush without significant pressure.Was still able to aspirate blood, and no signs of infiltration noted.Iv had to be discontinued and restarted as a result.Equipment failure resulted in patient receiving additional iv stick.

• Brand Name: INTROCAN SAFETY® 3
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 7391581
• MDR Text Key: 104174780
• Report Number: 7391581
• 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: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 05/01/2022
• Device Model Number: 4251129-02
• Device Catalogue Number: 4251129-02
• Device Lot Number: 17E23G8371
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 50 YR
• Patient Weight: 77