MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. GROSHONG 9.5 F DUAL-LUMEN CV CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 7726950 LOG59809

Device Problem Detachment Of Device Component (1104)

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

Event Date 06/16/2017

Event Type  malfunction  

Event Description

Patient has had a groshong catheter inserted and the original red port fell off 10 days later.Patient called the rn into the room to report the red port fell off, nothing was infusing at the time.

• Brand Name: GROSHONG 9.5 F DUAL-LUMEN CV CATHETER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 6791154
• MDR Text Key: 82577423
• Report Number: 6791154
• 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: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7726950 LOG59809
• Device Lot Number: REBQ1592
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/09/2017
• Event Location: Other
• Date Report to Manufacturer: 08/09/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 61 YR