MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ZENYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER BASIC KIT (11F) (DUAL-LUMEN) (15CM; CATHETER, HEMODIALYSIS, DUAL LUMEN, NON-IMPLANTED

Catalog Number	A853150
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 complaint of a kink in the catheter could not be verified since the original sample was not returned for investigation.Three unused zenysis d/l catheters were received in unopened kits.No damage was noted on the kits.The kits were opened and the catheters were removed for inspection.The unused catheters revealed no damage or defects.No kinks were observed in the d/l tubing.A tactual investigation revealed nothing remarkable.There was no tendency for the catheters to kink.The d/l tubing was cut just distal to the bifurcation and 2.5cm distal to the bifurcation.The wall and septum thickness of the tubing were within specification.The extension leg was also within specification.The reported event could not be tied to a defect in manufacturing of the returned samples.Kinking could be related to the position of the catheter during use.The product ifu states, ¿catheters should be implanted carefully to avoid any sharp or acute angles which could compromise the opening of the catheter lumens.¿ no further action is required because the complainant event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of reap1683 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reap1683) have been reported from the same facility.
Event or Problem Description
On (b)(6) 2016 - per sales representative, facility reported that a zenysis catheter became kinked and collapsed at the "neck" of the catheter during plasmapheresis.It was stated that the catheter needed to be replaced within 24 hours of placement.This event addresses catheter two.

• Brand Name: ZENYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER BASIC KIT (11F) (DUAL-LUMEN) (15CM
• Common Device Name: CATHETER, HEMODIALYSIS, DUAL LUMEN, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5906375
• Report Number: 3006260740-2016-00458
• Device Sequence Number: 18946559
• Product Code: MPB
• UDI-Device Identifier: 00801741109744
• UDI-Public: (01)00801741109744(17)180228(10)REAP1683
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K153190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2016

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: 02/28/2018
• Device Catalogue Number: A853150
• Device Lot Number: REAP1683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2016
• Initial Report FDA Received Date: 08/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1