MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER-TRIALYSIS SHORT-TERM CURVED DIALYSIS 13F TL 15CM; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	5618150
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a difficult dilator insertion is confirmed but the exact cause remains unknown.One 15 cm powertrialysis catheter was returned opened.The product label indicated lot: reeu4034.Two 11-13 fr dilators, one 12-14 fr dilator, one guidewire, and one introducer needle included within the kit.The additional 11-13 fr dilator was likely removed from a separate kit.Blood residue was present on each of the three dilators.Deformation and material whitening was visible on one of the 11-13 fr dilators and on the 12-14 fr dilator.Microscopic observation of the two damaged dilators revealed them to be flared outwards and non-concentric.The flared regions appeared to have a point of localized deformation which may have been caused by forceful advancement against a guidewire.No apparent deformation was noted on the returned guidewire; however, it is unknown if a guidewire from the separate kit was used.Since the deformation was observed on the dilators to suggest a difficult insertion, the complaint is confirmed but the exact cause is unknown.A lot history review (lhr) of reeu4034 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that dilator could not get inserted at puncture site.(b)(6) 2021: the returned dilator was found to be flared outward.

• Brand Name: POWER-TRIALYSIS SHORT-TERM CURVED DIALYSIS 13F TL 15CM
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11757264
• Report Number: 3006260740-2021-01635
• Device Sequence Number: 3527106
• Product Code: NIE
• UDI-Device Identifier: 00801741041983
• UDI-Public: (01)00801741041983
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/13/2021

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: 5618150
• Device Catalogue Number: 5618150
• Device Lot Number: REEU4034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2021
• Initial Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other