MAUDE Adverse Event Report: BARD ACCESS SYSTEMS VAS-CATH NIAGARA KIT 13.5 F X 15 CM [PRE-CURVED SHORT TERM DUAL-LUMEN]; NON-IMPLANTED BLOOD ACCESS DEVICE

Model Number	5594150
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	07/20/2017
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reaz0008 showed no other similar product complaint(s) from this lot number.Device not returned, at this time.
Event or Problem Description
The doctor was performing an acute dialysis catheter insertion yesterday, using the ultrasound.The doctor reported the catheter was inserted and the following day it had cracked.There was slight bleeding.No patient injury was reported.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a crack in the extension leg was confirmed, but the exact cause was unknown.One 15cm pre-curved niagara catheter was returned for investigation.Splits were observed in each extension leg, which allowed fluid to leak from the catheter.It was reported that the catheter was cracked a day after the catheter was placed.Evidence of use and wear were observed on the catheter.The printing on the extension legs and bifurcation was partially worn.The distal 3cm of each extension leg was discolored.The distal 1cm of each extension leg exhibited what appeared to be crazing.The splits in the catheter could be attributable to chemical degradation; however, the exact cause of the observed damage was unknown.The product ifu warns, ¿acetone and peg-containing ointments can cause failure of this device and should not be used with polyurethane catheters.¿.
Event or Problem Description
The doctor was performing an acute dialysis catheter insertion yesterday, using the ultrasound.The doctor reported the catheter was inserted and the following day it had cracked.There was slight bleeding.No patient injury was reported.

• Brand Name: VAS-CATH NIAGARA KIT 13.5 F X 15 CM [PRE-CURVED SHORT TERM DUAL-LUMEN]
• Common Device Name: NON-IMPLANTED BLOOD ACCESS DEVICE
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6788500
• Report Number: 3006260740-2017-01287
• Device Sequence Number: 13703014
• Product Code: MPB
• UDI-Device Identifier: 00801741045608
• UDI-Public: (01)00801741045608
• Combination Product (Y/N): N
• Initial Reporter Country: KE
• PMA/510(K) Number: K030268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2017

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: 11/30/2019
• Device Model Number: 5594150
• Device Catalogue Number: 5594150
• Device Lot Number: REAZ0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 08/11/2017
• Supplement Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 55