MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER-TRIALYSIS SHORT-TERM ALPHACURVE DIALYSIS CATHETER KIT 13F BASIC KIT (TRIPL; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was confirmed and the cause was determined to be manufacturing related.No physical devices were returned for assessment.It was determined during a plant investigation of this complaint event that the incorrect catheter was used to build the kit.A lot history review (lhr) of redr0440 showed two other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.
Event or Problem Description
It was reported that there was a 12.5cm trialysis inside of a 15cm kit packaging.Facility stated this occurred with three kits.This report addresses the third kit.

• Brand Name: POWER-TRIALYSIS SHORT-TERM ALPHACURVE DIALYSIS CATHETER KIT 13F BASIC KIT (TRIPL
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9098117
• Report Number: 3006260740-2019-02765
• Device Sequence Number: 14109179
• Product Code: NIE
• UDI-Device Identifier: 00801741066023
• UDI-Public: (01)00801741066023
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall,Other
• Type of Report: Initial
• Report Date (Section B): 09/20/2019

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: N/A
• Device Catalogue Number: 5653150
• Device Lot Number: REDR0440
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1