MAUDE Adverse Event Report: BARD ACCESS SYSTEMS OTW, 14.5 FR, 23CM, ST, SPLIT TIP, STANDARD KIT; LONG-TERM HEMODIALYSIS CATHETER

Model Number	5903230
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiration date: 03/2020).
Event or Problem Description
It was reported that the tip of the tunneler allegedly broke after the catheter had been successfully placed, and the tunneler had been removed from the patient.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturer review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.Investigation summary: a sample evaluation could not be performed, as the device was not returned.However, one electronic photo was provided for review.The photo shows an broken portion of the tunneler connector tip.Based on this photo review, the broken tunneler can be confirmed.The exact root cause for the damaged tunneler could not be determined.However, it is likely that supplier issues may have contributed to reported event.
Event or Problem Description
It was reported that the tip of the tunneler allegedly broke after the catheter had been successfully placed, and the tunneler had been removed from the patient.There was no reported patient injury.

• Brand Name: OTW, 14.5 FR, 23CM, ST, SPLIT TIP, STANDARD KIT
• Common Device Name: LONG-TERM HEMODIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8562885
• Report Number: 3006260740-2019-01219
• Device Sequence Number: 13837165
• Product Code: MSD
• UDI-Device Identifier: 00801741013706
• UDI-Public: (01)00801741013706
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K090101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2019

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: 5903230
• Device Catalogue Number: 5903230
• Device Lot Number: RECX3053
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1