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

Model Number	5913230
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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: 09/2020.
Event or Problem Description
It was reported that the tip of the dilator allegedly broke.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.Investigation summary: although the sample was not returned for evaluation, one electronic photo was provided for review.The investigation is inconclusive for damaged/defective dilator tip, as the photo review could not confirm a deficiency/ functional issue.The definitive root cause could not be determined based upon available information.As only an electronic photograph was returned, the alleged device could not be examined further.It is unknown if procedural issues contributed to the reported 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.
Event or Problem Description
It was reported that the tip of the dilator allegedly broke.There was no reported patient injury.

• Brand Name: OTW, XK, 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: 8675553
• Report Number: 3006260740-2019-01562
• Device Sequence Number: 14208403
• Product Code: MSD
• UDI-Device Identifier: 00801741013843
• UDI-Public: (01)00801741013843
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K090101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2019

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: 5913230
• Device Catalogue Number: 5913230
• Device Lot Number: RECX3719
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 09/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1