MAUDE Adverse Event Report: BARD GROSHONG 9.5F DUAL-LUMEN CV CATHETER WITH SURECUFF TISSUE INGROWTH CUFF INTERMED; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	7726950
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rebq1592 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (rebq1592) have been reported from the same facility.The device has yet to be returned for evaluation.
Event or Problem Description
It was reported by the facility, via medwatch, that the patient had a right groshong placement and they noticed 4 days later that the red part of the lumen became disconnected from the groshong catheter.It was noted that it was just found "undone" from the catheter while chemo was infusing.

• Brand Name: GROSHONG 9.5F DUAL-LUMEN CV CATHETER WITH SURECUFF TISSUE INGROWTH CUFF INTERMED
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD; po box 42487; philadelphia PA 19101
• MDR Report Key: 6866764
• Report Number: 3006260740-2017-01621
• Device Sequence Number: 706415
• Product Code: FOZ
• UDI-Device Identifier: 00801741041570
• UDI-Public: (01)00801741041570
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K860256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/14/2017
• Report Date (Section F): 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 7726950
• Device Catalogue Number: 7726950
• Device Lot Number: REBQ1592
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/15/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Date Report Sent to FDA: 08/09/2017