MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER, ALPHACURVE, 14.5F STANDARD KIT (28CM); CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	5735230
Medical Device Problem Codes	Material Deformation (2976); Mushroomed (2987)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images 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.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.The information provided by bard 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 bard.
Event or Problem Description
It was reported that while accessing the lumen the catheter bubbled between the bifurcation and the hub.The catheter was removed and a new device was placed.There was no reported patient injury.
Additional Manufacturer Narrative
It was identified that the fda rn number was incorrect and the correct fda rn number is (b)(4).This number will not be changed on the emdr so that this report will remain connected and identify that the event was reported to the fda in a timely manner.The appropriate fields were updated accordingly.Manufacturing review: the device history records have been reviewed with special attention to the subassemblies, material review reports, raw material testing, manufacturing process, and quality control inspection.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 that has been reported for this corporate lot number to date.Investigation summary: the device was returned and evaluated.Visual and functional evaluation was performed.The investigation was confirmed for catheter aneurysm, as a bulge in the extension tubing was found.However, the definitive root cause could not be determined based upon available information.It is unknown if procedural issues contributed to the reported event.A possible root cause is exposure to incompatible chemicals.Labeling review: a review of the product instructions for use (ifu) procedural instructions, indications, warnings, precautions, cautions, possible complications and contraindications showed that the product labeling is adequate.Ifu states, "acetone and peg-containing ointments can cause failure of this device and should not be used with polyurethane catheters.Chlorhexidine patches or bacitracin zinc ointments (e.G., polysporin* ointment) are the preferred alternative.".
Event or Problem Description
It was reported that while accessing the lumen the catheter bubbled between the bifurcation and the hub.The catheter was removed and a new device was placed.There was no reported patient injury.

• Brand Name: HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER, ALPHACURVE, 14.5F STANDARD KIT (28CM)
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7509104
• Report Number: 2020394-2018-00654
• Device Sequence Number: 19188782
• Product Code: MSD
• UDI-Device Identifier: 00801741013195
• UDI-Public: (01)00801741013195
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K030020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2018

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: 06/30/2019
• Device Model Number: 5735230
• Device Catalogue Number: 5735230
• Device Lot Number: REBU0200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 10/04/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 10/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 123