MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER FULL PROCEDURE TRAY 13 F; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	5605150
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 recs3172 showed three other similar product complaint(s) from this lot number.The complaints for this lot number (recs3172) have been reported from the same facility.
Event or Problem Description
The facility reported that they pulled a new catheter out of a kit to test and determined that there appears to be leaking of air into the arterial extension leg at the junction to the hub of the catheter (where the suture holes are).
Additional Manufacturer Narrative
The initial complaint appeared to be a reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had not occurred.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 catheter leak was unconfirmed because the problem could not be reproduced.The product returned for evaluation was a 15cm trialysis catheter.The sample appeared clean and unused.No evidence of blood usage, infusion residue, or other indication of use was observed.A gross visual evaluation of the device found no potential evidence of a hole or leakage source.Further functional testing included purposefully occluding the catheter and while applying forceful infusion of water through each lumen, in turn.No leakage was produced during forceful infusion, including while simultaneously manipulating the interfacing components.Microscopic examination of the arterial luer, extension leg, and corresponding catheter lumen was unremarkable.No damage was observed.As the described event could not be reproduced, and no potential cause of leakage was observed, the complaint was unconfirmed.A lot history review (lhr) of recs3172 showed three other similar product complaint(s) from this lot number.The complaints for this lot number (recs3172) have been reported from the same facility.Mw5079501.
Event or Problem Description
The facility reported that they pulled a new catheter out of a kit to test and determined that there appears to be leaking of air into the arterial extension leg at the junction to the hub of the catheter (where the suture holes are).

• Brand Name: POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER FULL PROCEDURE TRAY 13 F
• 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: 7857223
• Report Number: 3006260740-2018-02405
• Device Sequence Number: 11192603
• Product Code: NIE
• UDI-Device Identifier: 00801741086953
• UDI-Public: (01)00801741086953
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2018
• Report Date (Section F): 08/28/2018

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: 5605150
• Device Catalogue Number: 5605150
• Device Lot Number: RECS3172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2018
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2018
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 10/19/2018
• 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: 08/28/2018