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

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

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

Event Date 05/19/2017

Event Type  malfunction  

Event Description

The red port to the groshong catheter fell off while gently flushing it. The blue port remained intact, the line was being prepared to start a chemo infusion, a repair of the catheter was performed. The catheter port was sequestered.

• 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: 6692475
• MDR Text Key: 79251606
• Report Number: 6692475
• 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

• Type of Report: Initial
• Report Date: 07/05/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 7726950
• Device Catalogue Number: 7726950
• Device Lot Number: REBQ1592
• Was Device Available for Evaluation?: Yes

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/05/2017
• Event Location: Other
• Date Report to Manufacturer: 07/05/2017
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage