MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERTRIALYSIS TRIPLE LUMEN 20 CM; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of redt1564 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in the (b)(6).
Event or Problem Description
It was reported that after puncturing the vessel the wire twisted and the catheter couldn´t be inserted, requiring the patient be punctured and cannulated again.It was stated this happened in two cases with the same batch.No other information was provided.This report addresses the first of two cases.
Event or Problem Description
It was reported that after puncturing the vessel the wire twisted and the catheter couldn´t be inserted, requiring the patient be punctured and cannulated again.It was stated this happened in two cases with the same batch.No other information was provided.This report addresses the first of two cases.
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd 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 bd.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redt1564 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in the czech republic.

• Brand Name: POWERTRIALYSIS TRIPLE LUMEN 20 CM
• 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: 9857663
• Report Number: 3006260740-2020-00918
• Device Sequence Number: 14046601
• Product Code: NIE
• UDI-Device Identifier: 00801741041907
• UDI-Public: (01)00801741041907
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2020

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: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 5608200
• Device Lot Number: REDT1564
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/27/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 05/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1