MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 RELIANCE XK LONG-TERM HEMODIALYSIS CATHETER

Model Number	5323230
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/13/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
The lot number was provided and a complaint history review will be performed.The sample was not returned to the manufacturer for inspection/ evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/ patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiration date: 9/2020).
Event or Problem Description
It was reported that during dialysis catheter placement in the right internal jugular access, the introducer catheter allegedly malpositioned.It was further reported that the catheter was removed, allegedly causing the patient to become hemodynamically compromised.Reportedly, the patient was resuscitated, and a sternotomy revealed a superior vena cava injury.The patient reportedly expired.
Event or Problem Description
It was reported that during dialysis catheter placement in the right internal jugular access, the introducer catheter allegedly malpositioned.It was further reported that the catheter was removed, allegedly causing the patient to become hemodynamically compromised.Reportedly, the patient was resuscitated, and a sternotomy revealed a superior vena cava injury.The patient reportedly expired.
Additional Manufacturer Narrative
H10: the previously submitted emdr inaccurately reported the g4 date.The g4 date should have been reported as (b)(6) 2020.H10: the lot number was provided and a complaint history review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4 (expiration date: 9/2020).H11: b1, g4.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.

• Brand Name: RELIANCE XK LONG-TERM HEMODIALYSIS CATHETER
• Common Device Name: LONG-TERM HEMODIALYSIS CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10646110
• Report Number: 3006260740-2020-20008
• Device Sequence Number: 16802183
• Product Code: MSD
• UDI-Device Identifier: 00801741011993
• UDI-Public: (01)00801741011993
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5323230
• Device Catalogue Number: 5323230
• Device Lot Number: RECX3112
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 10/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death