MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 8F SINGLE-LUMEN CV CATHETER WITH SURECUFF TISSUE INGROWTH CUFF INTERMED; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	Complaint, Ill-Defined (2331)
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) of rerd0024 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Patient reported to medical services & support that she had a groshong cvc placed in 2007, and the catheter needs to be repaired due to home healthcare "messing" up the catheter.The catheter will flush and aspirate with out issue, however, patient is having bleed back.Patients states she was informed that the catheter was obsolete.She contacted ms&s inquiring about a yellow connector as she has 3 inches of catheter that could be repaired.Patient is scheduled to see her physician to have her groshong cvc evaluated for repair or replacement.Ms&s advised the patient that the device is not obsolete.No patient injury was reported.

• Brand Name: GROSHONG 8F SINGLE-LUMEN CV CATHETER WITH SURECUFF TISSUE INGROWTH CUFF INTERMED
• 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: 6959943
• Report Number: 3006260740-2017-01851
• Device Sequence Number: 13574039
• 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): 10/18/2017

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: N/A
• Device Catalogue Number: 7711800
• Device Lot Number: RERD0024
• Was Device Available for Evaluation?: No
• Event Location: Home
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1