MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (27CM); CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	5833270
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.Photographs have been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that during catheter placement both lumens were collapsed at the level of the clamps.The catheter was removed and a new device was placed.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary:the sample was not returned for evaluation; however two photos were provided and reviewed.The photo review confirmed that the reported kinks were present in the extension legs.Therefore, the investigation is confirmed for the reported catheter kink.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Potential contributing factors include repeated clamping in the same location, excessive force, mechanical damage and chemical degradation.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported that during catheter placement both lumens were collapsed at the level of the clamps.The catheter was removed and a new device was placed.There was no reported patient injury.

• Brand Name: HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER 14.5F STANDARD KIT (STRAIGHT) (27CM)
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7997739
• Report Number: 3006260740-2018-02992
• Device Sequence Number: 13503617
• Product Code: MSD
• UDI-Device Identifier: 00801741013324
• UDI-Public: (01)00801741013324
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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: 07/31/2019
• Device Model Number: 5833270
• Device Catalogue Number: 5833270
• Device Lot Number: REBW1546
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1