MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 19 CM HEMOSTAR ALPHACURVE STANDARD KIT; DIALYSIS CATHETER

Model Number	5835150
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
Manufacturing review: a lot history review, a dhr review, and complete manufacturing review could not be conducted for the investigation 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: one 4.5 fr d/l hemostar 19 cm alphacurve hemodialysis catheter with surecuff device was returned for evaluation.Functional and dimensional evaluations were performed.The investigation is unconfirmed for decreased catheter patency due to kinked catheter, as the device functioned properly under laboratory conditions and the reported event could not be reproduced.Although a definitive root cause could not be determined, repeated clamping over the same spot on the catheter could have potentially caused or contributed to the reported event.
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 the patient continued to received reduced-efficiency dialysis treatments.Reportedly, the device was removed and replaced.There was no reported patient injury.

• Brand Name: 19 CM HEMOSTAR ALPHACURVE STANDARD KIT
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8870357
• Report Number: 3006260740-2019-02318
• Device Sequence Number: 10840547
• Product Code: MSD
• UDI-Device Identifier: 00801741013485
• UDI-Public: (01)00801741013485
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2019

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: 5835150
• Device Catalogue Number: 5835150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 08/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1