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	03/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A photo has been provided to the manufacturer for review.The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that upon opening the package, the tunneler was allegedly found in pieces.There was no patient contact.
Additional Manufacturer Narrative
Manufacturing review: the lot met all release criteria.Manufacturing records were reviewed (dhr, mrr¿s, scrap and mfg.Process changes) and there were not found evidence that the failure mode reported in this complaint is caused by the mfg.Process.Investigation summary:although the sample was not returned for evaluation, one electronic photo was provided for review.The investigation is confirmed for tunneler break, as the photograph showed the blue tunneler connection tip in pieces.The root cause of the event has been determined to be supplier-related.Labeling review: as this event has been determined to be supplier-related, a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) is not applicable; labeling would not have prevented this event.
Event or Problem Description
It was reported that upon opening the package, the tunneler was allegedly found in pieces.There was no patient contact.

• 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: 8489421
• Report Number: 3006260740-2019-00807
• Device Sequence Number: 2689702
• Product Code: MSD
• UDI-Device Identifier: 00801741013843
• UDI-Public: (01)00801741013843
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 05/23/2019

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 Expiration Date: 09/30/2020
• Device Model Number: 5913230
• Device Catalogue Number: 5913230
• Device Lot Number: RECX3719
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1