MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER TRIALYSIS, INTL, 20CM, ST, ACUTE DIALYSIS KIT; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON IMPLANTED

Catalog Number	5608200
Health Effect - Clinical Code	No Information (3190)
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) of rebn0151 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that when using a powertrialysis, the wire could not be retracted and physician had to remove the complete catheter again.
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 that the wire could not be retracted through the catheter was inconclusive since the wire was not returned for investigation.The returned trialysis catheter revealed no obstructions and resistance was not observed when passing an unused 0.035¿ guidewire through the power injectable lumen.The reported event could not be replicated with the catheter.Since the guidewire was not returned for investigation, it is unknown if the wire was a contributing factor.The returned catheter functioned according to design.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.
Event or Problem Description
It was reported that when using a powertrialysis, the wire could not be retracted and physician had to remove the complete catheter again.

• Brand Name: POWER TRIALYSIS, INTL, 20CM, ST, ACUTE DIALYSIS KIT
• 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: 6588646
• Report Number: 3006260740-2017-00680
• Device Sequence Number: 838346
• Product Code: NIE
• UDI-Device Identifier: 00801741041907
• UDI-Public: (01)00801741041907(17)200531(10)REBN0151
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2017

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: 05/31/2020
• Device Catalogue Number: 5608200
• Device Lot Number: REBN0151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/19/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/24/2017
• Supplement Report FDA Received Date: 06/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1