MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR XK LONG-TERM HEMODIALYSIS CATHETER 16F STANDARD KIT (STRAIGHT) (23CM); BLOOD ACCESS AND ACCESSORIES

Catalog Number	5883730
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
On (b)(6) 2016 - it was reported by complainant that during the procedure the dialysis device "did not work".Contact stated that there was a hole in the catheter.On (b)(6) 2016 - despite multiple attempts during placement, the dialysis catheter could not be advanced over the wire and facility reported that access was lost.
Additional Manufacturer Narrative
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.The initial complaint appeared to be a reportable occurrence.Once the sample was returned, investigation revealed no device malfunction.The reported events could not be reproduced.The information provided does not reasonably suggest the event may have caused or contributed to a death or serious injury of a patient, user or other person.Therefore this event is deemed not reportable per 21 cfr part 803.

• Brand Name: HEMOSTAR XK LONG-TERM HEMODIALYSIS CATHETER 16F STANDARD KIT (STRAIGHT) (23CM)
• Common Device Name: BLOOD ACCESS AND ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5806839
• Report Number: 3006260740-2016-00360
• Device Sequence Number: 387317
• Product Code: MSD
• UDI-Device Identifier: 00801741013607
• UDI-Public: (01)00801741013607
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2016

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: 01/28/2018
• Device Catalogue Number: 5883730
• Device Lot Number: REAS0741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2016
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/19/2016
• Supplement Report FDA Received Date: 08/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1