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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DISTAFLO BYPASS GRAFT
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BARD PERIPHERAL VASCULAR, INC. DISTAFLO BYPASS GRAFT Back to Search Results
Model Number DFM8006SC
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 lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation.The investigation is confirmed for graft tear.A definitive root cause for the reported event could not be determined.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 dfm8006sc bypass graft allegedly experienced material split.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The weight of (b)(6) year old male patient was not provided.
 
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Brand Name
DISTAFLO BYPASS GRAFT
Common Device Name
BYPASS GRAFT
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key10750348
Report Number2020394-2020-06196
Device Sequence Number3140679
Product Code DSY
UDI-Device Identifier00801741000164
UDI-Public(01)00801741000164
Combination Product (Y/N)N
Initial Reporter StateAZ
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/28/2020
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 NumberDFM8006SC
Device Catalogue NumberDFM8006SC
Device Lot NumberVTDX0672
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/30/2020
Initial Report FDA Received Date10/28/2020
Patient Sequence Number1
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