MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER-TRIALYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER KIT 13F (TRIPLE-LU; 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)
Date of Event	08/19/2020
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 recs3182 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the catheter twists or expands before introduction.No other information was provided.
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, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a catheter kink is confirmed but the exact cause could not be determined from the images provided.Two photo samples of a powertrialysis catheter was provided for evaluation.The first photo sample shows the catheter outside of patient use.Blood residue is present on the drapes and catheter surface.A guidewire is visible extending from the distal end of the catheter.Two bends in the catheter shaft are visible approximately 1 cm from each other.The second image shows the guidewire and appears to be partially within the patient.A kink in the guidewire is present.The deformation on the guidewire and catheter suggest the catheter likely experienced resistance during advancement.Based on the images provided, possible contributing factors include insertion angle, incision size, and advancement technique.The complaint of a kinked catheter during insertion is confirmed; however, the exact cause remains unknown.A lot history review (lhr) of recs3182 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the catheter twists or expands before introduction.No other information was provided.

• Brand Name: POWER-TRIALYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER KIT 13F (TRIPLE-LU
• 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: 10512059
• Report Number: 3006260740-2020-03193
• Device Sequence Number: 11401544
• Product Code: NIE
• UDI-Device Identifier: 00801741042003
• UDI-Public: (01)00801741042003
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2020

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: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 5618240
• Device Lot Number: RECS3182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 10/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1