MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER-TRIALYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER KIT (13F) (24CM); CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.[mw5080432.Pdf].
Event or Problem Description
It was reported by medwatch that: "trialysis catheter started leaking from blue return side of catheter due to fracture.".
Event or Problem Description
It was reported by medwatch that: "trialysis catheter started leaking from blue return side of catheter due to fracture.".
Additional Manufacturer Narrative
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, 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 leak in the power-trialysis catheter was confirmed, but the exact mechanism of damage could not be determined.One 15cm power-trialysis catheter with pre-curved extension legs was returned for investigation.The catheter showed evidence of use.What appeared to be blood residue was observed within the catheter.Residue was observed on the trifurcation and connectors.A functional test revealed a leak in the venous extension leg at the proximal end of the molded trifurcation.No other leaks were observed in the tubing.The adjoining surfaces of the tubing at the leak site were rough and granular, which is indicative of a tear.The split was in the circumferential direction.Due to the evidence of use, it appears that the hole developed after placement.Flexing, twisting, or pulling the extension leg tubing may have been contributing factors that may have led to material fatigue; however, the exact mechanism of damage was unknown.The reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.A lot history review (lhr) of recq0159 showed no other similar product complaint(s) from this lot - attachment: [mw5080432 rga1277186.Pdf].

• Brand Name: POWER-TRIALYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER KIT (13F) (24CM)
• 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: 8189399
• Report Number: 3006260740-2018-03636
• Device Sequence Number: 19519321
• Product Code: NIE
• UDI-Device Identifier: 00801741041969
• UDI-Public: (01)00801741041969
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2019
• Report Date (Section F): 10/05/2018

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 Model Number: N/A
• Device Catalogue Number: 5613150
• Device Lot Number: RECQ0159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2018
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 10/05/2018