MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 24 CM HEMOSTAR ALPHACURVE STANDARD KIT; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	5835190
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Expiry date(10/2019).
Event or Problem Description
It was reported that approximately 73 days post port placement an alleged fissuring (split or crack) was identified in close proximity of the triangular connection in the pre-curved catheter.It was further reported that patient hospitalization for urgent replacement was required.Patient status was not provided.

• Brand Name: 24 CM HEMOSTAR ALPHACURVE STANDARD KIT
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10003005
• Report Number: 3006260740-2020-01516
• Device Sequence Number: 16886179
• Product Code: MSD
• UDI-Device Identifier: 00801741013492
• UDI-Public: (01)00801741013492
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5835190
• Device Catalogue Number: 5835190
• Device Lot Number: RECR1305
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 04/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention