MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR® LONG-TERM HEMODIALYSIS CATHETER

Model Number	5834420
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
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 when extension legs were unclamped, they allegedly remained collapsed, flat, and narrow, causing restriction in blood flow through the ports of the cvc, reduction in pump speed and reduction in clearance in the dialysis treatment.There was no reported patient injury.
Event or Problem Description
It was reported that sometime post dialysis catheter placement, when the extension leg was unclamped, the lumen remained collapsed, flat, and narrow, causing restriction of blood flow, reduction in pump speed, and reduction in clearance in the dialysis treatment.It was further reported that device was removed and replaced.Reportedly, the patient continued to received reduced-efficiency dialysis treatments.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: neither a lot history review nor dhr review can be performed, as the lot number is unknown 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.Investigation summary: although the sample was not returned for evaluation, one electronic photo was provided for review.The investigation is inconclusive for kink in extension, as the device in the photo was a different device from the alleged device.The definitive root cause could not be determined based upon available information.Potential contributors to the reported event are repeated clamping at the same location and poor material choice.It is unknown if procedural issues contributed to the reported event.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.

• Brand Name: HEMOSTAR® 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: 8552926
• Report Number: 3006260740-2019-01196
• Device Sequence Number: 1731214
• Product Code: MSD
• UDI-Device Identifier: 00801741013461
• UDI-Public: (01)00801741013461
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2019

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: 5834420
• Device Catalogue Number: 5834420
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1