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

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Hematoma (1884)
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) of reds1423 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "when the wire was inserted, there was a feeling that it did not go smoothly." the patient had a hematoma on insertion site due to extended procedure time.
Event or Problem Description
It was reported "when the wire was inserted, there was a feeling that it did not go smoothly." the patient had a hematoma on insertion site due to extended procedure time.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of difficult guidewire insertion could not be confirmed from the sample provided.One 70 cm guidewire within the hoop and one introducer needle were returned for investigation.No apparent damage or material deformation was observed with the guidewire.The guidewire was inserted through an 18 ga introducer needle and was able to pass through without issues.The outer diameter of the guidewire was measured and found to be within manufacturing specification.Microscopic observation of the needle bevel revealed material deformation consistent with damage caused by retraction of the guidewire against the needle bevel.Guidewire retraction against the needle bevel may have been contributed to the alleged event; however, the exact cause of a rough insertion could not be determined.A lot history review (lhr) of reds1423 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWER-TRIALYSIS SHORT-TERM CURVED EXTENSION DIALYSIS CATHETER KIT 13F (TRIPLE-L
• 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: 9342059
• Report Number: 3006260740-2019-03589
• Device Sequence Number: 2852621
• 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: foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 5618150
• Device Lot Number: REDS1423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/29/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1