MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UDC 6F PIGTAIL; DRAINAGE CATHETER

Catalog Number	NNU6PT
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review will be performed.The device has been returned for evaluation; the evaluation confirmed a connector break/crack.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one (1) malfunction.A review of the reported information indicated that model nnu6pt drainage catheter allegedly experienced a crack.This information was received from one source.The malfunction did not involve a patient as there was no patient contact.

• Brand Name: UDC 6F PIGTAIL
• Common Device Name: DRAINAGE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8822919
• Report Number: 3006260740-2019-02191
• Device Sequence Number: 2715931
• Product Code: GBX
• UDI-Device Identifier: 00801741036972
• UDI-Public: (01)00801741036972
• 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): 07/24/2019

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: No Information
• Device Catalogue Number: NNU6PT
• Device Lot Number: GFCW2955
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/24/2019
• Patient Sequence Number: 1