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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. SK9018; SEEKER CROSSING SUPPORT CATHETER
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BARD PERIPHERAL VASCULAR, INC. SK9018; SEEKER CROSSING SUPPORT CATHETER Back to Search Results
Model Number SK9018
Medical Device Problem Codes Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation; the evaluation could not identify a break or device-device incompatibility issue.Based upon the available information, a 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 sk9018 support catheter allegedly experienced device-device incompatibility and a break.This information was received from one source.This information was received from one source.The malfunction involved one patient with no patient consequences.The age, weight, and gender of the patient were not provided.
 
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Brand Name
SK9018
Common Device Name
SEEKER CROSSING SUPPORT CATHETER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key9963896
Report Number2020394-2020-02730
Device Sequence Number2546601
Product Code DQY
UDI-Device Identifier00801741067945
UDI-Public(01)00801741067945
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) 04/15/2020
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 NumberSK9018
Device Catalogue NumberSK9018
Device Lot NumberVTCV0299
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/31/2020
Initial Report FDA Received Date04/15/2020
Patient Sequence Number1
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