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

Model Number	N/A
Medical Device Problem Codes	Defective Component (2292); Material Twisted/Bent (2981)
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 reds3522 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.01/01/2019 hematoma was treated with pressure therapy and was resolved.
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.(b)(6) 2019 hematoma was treated with pressure therapy and was resolved.
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 a difficult wire insertion is confirmed but the exact cause remains unknown.One 70 cm guidewire within the hoop and an introducer needle were returned for investigation.Dried red residual material was present throughout the sample.A curve in the guidewire was present 2.5 cm from the distal end.The proximal 3 cm of the guidewire was also bent and had additional waviness.Microscopic observation of the needle bevel did not reveal any apparent deformation that may have been caused by the guidewire.The guidewire was inserted through an 18 ga introducer needle and was able to pass through.Resistance was felt when inserting the proximal end of the guidewire due to the bends in the wire.The outer diameter of the guidewire was measured and was found to be within manufacturing specification.Based on the condition of the returned guidewire, possible contributing factors include advancement against resistance and patient condition.Since the bends in the guidewire suggest a difficult insertion was likely experienced, the complaint is confirmed.A lot history review (lhr) of reds3522 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWER-TRIALYSIS SHORT-TERM CURVED EXTENSION 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: 9341972
• Report Number: 3006260740-2019-03588
• Device Sequence Number: 2801570
• 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): 12/23/2019

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: 5618200
• Device Lot Number: REDS3522
• 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: 12/19/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1