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

Model Number	5608200
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2018
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 a dialysis catheter was inserted in a patient and there was difficulty in advancing the guidewire.The wire could not be advanced and kinked several times.As usual, the vein was punctured, wire inserted without resistance, needle removed and dilated.The problem was allegedly with insertion from the catheter, there was a reportedly greater resistance and could not be advanced.Thereupon the insert was broken off and the wire was removed.When removing it has been noticed that the wire was kinked.
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 kinked guidewire is confirmed but the exact cause is unknown.One 20 cm trialysis catheter, one 13f and 14f dilators, a guidewire, and one plastic protective tubing were returned for investigation.A kink was observed on the guidewire approximately 45 mm from the distal end and an ¿s¿ shaped bend at the distal end.Red colored residue was present on j-tip straightener and on the guidewire.Microscopic observation revealed the guidewire to be intact with use residue on the distal tip.The core wire was observed to be intact.The outer diameter of the guidewire was measured to be within specification.A non-complainant guidewire was inserted through the dilators returned and through the catheter and no obstructions were observed.Based on the description of the reported event and condition of the samples returned, possible contributing factors include advancement against resistance or into tissue.As the kink was observed on the guidewire returned, the complaint is confirmed but the exact cause is unknown.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 a dialysis catheter was inserted in a patient and there was difficulty in advancing the guidewire.The wire could not be advanced and kinked several times.As usual, the vein was punctured, wire inserted without resistance, needle removed and dilated.The problem was allegedly with insertion from the catheter, there was a reportedly greater resistance and could not be advanced.Thereupon the insert was broken off and the wire was removed.When removing it has been noticed that the wire was kinked.".

• Brand Name: POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER KIT 13F BASIC KIT
• 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: 7578083
• Report Number: 3006260740-2018-01268
• Device Sequence Number: 2221638
• Product Code: NIE
• UDI-Device Identifier: 00801741041907
• UDI-Public: (01)00801741041907
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2018

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: 5608200
• Device Catalogue Number: 5608200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/04/2018
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 07/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1