MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 8F SL CV CATHETER W/SURECUFF TISSUE INGROWTH CUFF; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	7711800
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/18/2017
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 for evaluation, as the device remains in the patient.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Remains in patient.
Event or Problem Description
Patient reported that she had a groshong cvc placed in (b)(6) of 2017.The catheter infuses without any problem, but is unable to aspirate.Physician performed a dye study indicated the catheter tip to be in the correct location and has no difficulties flushing the port, but is still unable to obtain blood return.Patient stated the physician told her the catheter was placed in the subclavian, but is sure the lack of blood return is not caused by pinch off.

• Brand Name: GROSHONG 8F SL CV CATHETER W/SURECUFF TISSUE INGROWTH CUFF
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7023096
• Report Number: 3006260740-2017-02019
• Device Sequence Number: 16499760
• Product Code: LJS
• UDI-Device Identifier: 00801741036743
• UDI-Public: (01)00801741036743
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K831386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 11/10/2017

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 Model Number: 7711800
• Device Catalogue Number: 7711800
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1