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 second 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 following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a bent guidewire was confirmed, but the cause of the reported damage could not be determined from the photographs that were provided for investigation.Two photographs were provided for investigation.One photo showed the product labeling with part number 5608200 and lot #redt1564.No similar complaints were reported with the same lot.The second photo showed a guidewire on a blue drape.The power trialysis catheter and other kit components were also visible on the drape.What resembled blood residue was observed on the blue drape beneath the guidewire.Four kinks/bends were observed in the guidewire between the single band mark near the j-tip and the distal triple band mark.One of the kinks was located at the double band mark.It was reported that the vessel was punctured, the wire twisted, and catheter couldn¿t be inserted, which indicates that the damage most likely occurred during the insertion process; however, the exact cause of the damage could not be determined from the photographs that were provided for investigation.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.
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 second of two cases.

• 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: 9857662
• Report Number: 3006260740-2020-00920
• Device Sequence Number: 14046600
• 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?: Device Returned to Manufacturer
• 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