MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HGSTAR, 14.5 FR, ST, 27CM, STAND; DIALYSIS CATHETER

Model Number	5833270
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: as the lot number for the device was provided, a manufacturing review will be performed.Investigation summary: a sample evaluation could not be performed as the samples were not returned therefore the investigation is inconclusive for the alleged catheter fractured issue due to the fact that no sample was returned for evaluation.A definitive root cause could not be determined.Labeling review: a review of product labeling documents (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.(expiration date: 03/2017).
Event or Problem Description
It was reported that some time post dialysis catheter placement, the catheter was allegedly fractured.Reportedly, the device was replaced.There was no reported patient injury.

• Brand Name: HGSTAR, 14.5 FR, ST, 27CM, STAND
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9513070
• Report Number: 3006260740-2019-03990
• Device Sequence Number: 2703033
• Product Code: MSD
• UDI-Device Identifier: 00801741013324
• UDI-Public: (01)00801741013324
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5833270
• Device Catalogue Number: 5833270
• Device Lot Number: REZD0734
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1