MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EQUISTREAM XK LONG-TERM HEMODIALYSIS CATHETER; DIALYSIS CATHETER, IMPLANTED, SUBCUTANEUOS, IMPLANTED

Model Number	5913350
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A photograph of the device was received for evaluation.The lot number for the device was provided.The device history records are currently under review.The device is not available for return.The investigation is currently underway.
Event or Problem Description
It was reported that upon unpacking, the tunneler tip allegedly was identified as broken.There was no reported patient contact.
Additional Manufacturer Narrative
Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: although the sample was not returned for evaluation, two electronic photos were provided for review.The investigation is confirmed for broken tunneler, as the photo review shows the entire equistream kit with the broken tunneler tip sitting on top of another component.The tunneler can be seen sitting with some other components where the tip base seems to show the break.The definitive root cause for the reported damaged tunneler issue could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.However, vt-sca-19-4398 is currently opened to address the issue and identify appropriate actions.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.(expiry date 09/2020).
Event or Problem Description
It was reported that upon unpacking, the tunneler tip allegedly was identified as broken.There was no reported patient contact.

• Brand Name: EQUISTREAM XK LONG-TERM HEMODIALYSIS CATHETER
• Common Device Name: DIALYSIS CATHETER, IMPLANTED, SUBCUTANEUOS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8373936
• Report Number: 3006260740-2019-00382
• Device Sequence Number: 2287963
• Product Code: MSD
• UDI-Device Identifier: 00801741013874
• UDI-Public: (01)00801741013874
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K090101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2019

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: 5913350
• Device Catalogue Number: 5913350
• Device Lot Number: RECZ0711
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2019
• Supplement Date Received by Manufacturer: 04/02/2019
• Initial Report FDA Received Date: 02/27/2019
• Supplement Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1