MAUDE Adverse Event Report: BARD ACCESS SYSTEMS S/L PERC 8FR 65D; CHRONIC CATHETER

Model Number	7711800
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the reported malfunction was provided, therefore a lot history review was performed.The device was not returned for evaluation.Therefore, the malfunction is inconclusive for nonstandard device.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model 7711800 chronic catheter allegedly experienced nonstandard device.This report was received from one source.One patient was involved with no patient contact.The patients¿ age, weight, and gender were not provided.

• Brand Name: S/L PERC 8FR 65D
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10289338
• Report Number: 3006260740-2020-02521
• Device Sequence Number: 812481
• Product Code: LJS
• UDI-Device Identifier: 00801741036743
• UDI-Public: (01)00801741036743
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/17/2020

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: No Information
• Device Model Number: 7711800
• Device Catalogue Number: 7711800
• Device Lot Number: REDS4889
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/17/2020
• Patient Sequence Number: 1