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

Model Number	5605150
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/23/2018
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 be evaluated.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that on (b)(6) 2018 the rn infused through the trialysis catheter and noticed a bulge in the extension leg.The catheter was removed and another one was replaced successfully.There was no patient injury reported.
Additional Manufacturer Narrative
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 bulge in the extension leg is confirmed but the exact cause is unknown.One powertrialysis 15 cm catheter was returned for investigation.A bulge in the venous extension tubing was observed.Use residue was present within the catheter.Yellowish discoloration was observed on extension tubing and appeared to be concentrated near the clamps.The discoloration may have been caused by excessive exposure to cleaning agents.The ifu states ¿clean exit site at each dialysis treatment with chlorhexidine gluconate unless contraindicated.Apply antiseptic per manufacturer¿s recommendations.Allow to air dry completely¿ and ¿warning: acetone and polyethylene glycol (peg)-containing ointments can cause failure of this device and should not be used with polyurethane catheters.¿ use of incompatible cleaning agents, excessive exposure to chemicals and over-pressurization may be contributing factors to the bulging of the extension leg.As the bulge in the extension leg was present, the complaint is confirmed but the exact cause is unknown.No further action is required because 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) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that on 6/23/18 the rn infused through the trialysis catheter and noticed a bulge in the extension leg.The catheter was removed and another one was replaced successfully.There was no patient injury reported.

• Brand Name: POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER FULL PROCEDURE TRAY 13F TL
• 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: 7770626
• Report Number: 3006260740-2018-02023
• Device Sequence Number: 1757189
• Product Code: NIE
• UDI-Device Identifier: 00801741086953
• UDI-Public: (01)00801741086953
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 08/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1