MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HGSTAR, 14.5 FR, ST, 15CM, STAND; DIALYSIS CATHETER

Model Number	5833150
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiration date: 09/2019).
Event or Problem Description
It was reported that during testing of the dialysis catheter, an alleged leak was found.There was no patient contact.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.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.Investigation summary: one 15cm hemostar catheter was returned for evaluation.Functional, gross visual, microscopic visual and tactile evaluations were performed.The investigation is confirmed for a catheter leak, specifically for an external leak/split without embolism, as a leak was observed just distal to the bifurcation during infusion of the blue hub.Surface damage was observed adjacent to the leak and the hole surface was observed to be smooth and uneven.These observations are consistent with characteristics of damage caused by handling/manipulating the catheter with tools (e.G.Hemostats).The definitive root cause could not be determined based upon available information.Manipulation of the catheter with tools (e.G.Hemostats), exposure to excessive forces and/or catheter degradation may have contributed to the reported event.However, it is unknown if procedural issues contributed to the reported event.
Event or Problem Description
It was reported that during testing of the dialysis catheter, an alleged leak was found.There was no patient contact.

• Brand Name: HGSTAR, 14.5 FR, ST, 15CM, STAND
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8528123
• Report Number: 3006260740-2019-00942
• Device Sequence Number: 11233863
• Product Code: MSD
• UDI-Device Identifier: 00801741013317
• UDI-Public: (01)00801741013317
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2019

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: 5833150
• Device Catalogue Number: 5833150
• Device Lot Number: REBZ1014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1