MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EQUISTREAM XK LONG-TERM HEMODIALYSIS CATHETER

Model Number	5913230
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently underway.
Event or Problem Description
It was reported that upon opening the package, the tunneler allegedly was identified broken.It was further reported that another device was used to complete the procedure.There was no patient contact.
Event or Problem Description
It was reported that upon opening the package, the tunneler allegedly was identified broken.It was further reported that another device was used to complete the procedure.There was no patient contact.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged broken tunneler as no objective evidence has been provided to confirm any alleged deficiency with the tunneler.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Possible contributing factors include damaged during production and damaged during shipping; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).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.

• Brand Name: EQUISTREAM XK LONG-TERM HEMODIALYSIS CATHETER
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8458349
• Report Number: 3006260740-2019-00701
• Device Sequence Number: 16897557
• Product Code: MSD
• UDI-Device Identifier: 00801741013843
• UDI-Public: (01)00801741013843
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2019

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: 5913230
• Device Catalogue Number: 5913230
• Device Lot Number: RECX3719
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 04/13/2019
• Initial Report FDA Received Date: 03/27/2019
• Supplement Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1