MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSPLIT XK, 16 FR, ST, 19CM, STAND KIT; DIALYSIS CATHETER

Model Number	5683690
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing 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.Medical device expiry date: 02/2018.
Event or Problem Description
It was reported that post catheter implantation in the right jugular vein, the connectors of the device allegedly broke.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a complaint history review was completed for the lot number.This is the first reported complaint for this lot number and this issue to date.Investigation summary: a sample evaluation could not be performed as the samples were not returned therefore the investigation is inconclusive for the alleged cracked connector issue due to the fact that no sample was returned for evaluation.The root cause could not be determined based upon available information.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.
Event or Problem Description
It was reported that post catheter implantation in the right jugular vein, the connectors of the device allegedly broke.There was no reported patient injury.

• Brand Name: HEMOSPLIT XK, 16 FR, ST, 19CM, STAND KIT
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10113840
• Report Number: 3006260740-2020-01927
• Device Sequence Number: 3852499
• Product Code: MSD
• UDI-Device Identifier: 00801741012716
• UDI-Public: (01)00801741012716
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: K033294
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2020

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: 5683690
• Device Catalogue Number: 5683690
• Device Lot Number: REAQ1074
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2020
• Supplement Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 06/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 40