MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DISTAFLO BYPASS GRAFT

Model Number	DF6007SC
Medical Device Problem Code	Material Split, Cut or Torn (4008)
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 for material split, cut or torn.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.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction event.A review of this event indicated that model df6007sc bypass graft experienced material split, cut or torn.This report was received from one source.There was a patient involved with no patient consequences.The patient is (b)(6) years of age and male.Patient weight was not provided.

• Brand Name: DISTAFLO BYPASS GRAFT
• Common Device Name: BYPASS GRAFT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8533232
• Report Number: 3006260740-2019-01095
• Device Sequence Number: 2431055
• Product Code: DSY
• UDI-Device Identifier: 00801741023545
• UDI-Public: (01)00801741023545
• 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): 04/19/2019

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 Model Number: DF6007SC
• Device Catalogue Number: DF6007SC
• Device Lot Number: VTCY0117
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 04/19/2019
• Patient Sequence Number: 1