MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DISTAFLO EPTFE VASCULAR GRAFT; DISTAFLO BYPASS GRAFT

Model Number	DFX8006SC
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
The device was returned to bd for evaluation.The investigation is identified for material split it was noted that the cuffs were detaching from the graft.Based on the information provided, the definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model dfx8006sc distaflo bypass graft allegedly experienced material split.This information was received from one source.This malfunction did involve a patient with no reported patient injury.The patient was a (b)(6) male weighing (b)(6) kgs.

• Brand Name: DISTAFLO EPTFE VASCULAR GRAFT
• Common Device Name: DISTAFLO BYPASS GRAFT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9193018
• Report Number: 2020394-2019-03945
• Device Sequence Number: 17084608
• Product Code: DSY
• UDI-Device Identifier: 00801741023675
• UDI-Public: (01)00801741023675
• 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): 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: DFX8006SC
• Device Catalogue Number: DFX8006SC
• Device Lot Number: VTDQ0597
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/15/2019
• Patient Sequence Number: 1