MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER FULL PROCEDURE TRAY 13 F; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	5605150
Health Effect - Clinical Code	Air Embolism (1697)
Type of Reportable Event	Serious Injury
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 device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recs3172 showed three other similar product complaint(s) from this lot number.The complaints for this lot number (recs3172) have been reported from the same facility.
Event or Problem Description
The facility reported an event in which a patient being treated with tl acute power dialysis catheter coded.When an ultrasound was performed, air was discovered in both the atrium and the ventricle.All of the department was notified to pay close attention to the tubing, machine, and catheter, and they were able to rule out the dialysis machine as the problem.

• Brand Name: POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER FULL PROCEDURE TRAY 13 F
• 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: 7857927
• Report Number: 3006260740-2018-02408
• Device Sequence Number: 16629463
• Product Code: NIE
• UDI-Device Identifier: 00801741086953
• UDI-Public: (01)00801741086953
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 5605150
• Device Catalogue Number: 5605150
• Device Lot Number: RECS3172
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention