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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO COAXIAL FEMORAL CANAL TIP; LAVAGE, JET
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STRYKER INSTRUMENTS-PUERTO RICO COAXIAL FEMORAL CANAL TIP; LAVAGE, JET Back to Search Results
Catalog Number 0210007000
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 06/30/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Reported events: 1 event was reported for this quarter.Product return status: 1 device was not available for evaluation.1 device was labeled for single-use.1 device was not reprocessed or reused.Device not returned.
 
Event or Problem Description
This report summarizes 1 malfunction event in which the device had a component detach.1 event had patient involvement; no patient impact.
 
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Brand Name
COAXIAL FEMORAL CANAL TIP
Common Device Name
LAVAGE, JET
Manufacturer (Section D)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 00615
PR  00615
MDR Report Key10329644
Report Number0001811755-2020-01887
Device Sequence Number2890072
Product Code FQH
UDI-Device Identifier34546540861130
UDI-Public34546540861130
Combination Product (Y/N)N
Initial Reporter StateMI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)Y
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/27/2020
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 Catalogue Number0210007000
Device Lot NumberVMSR
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/30/2020
Initial Report FDA Received Date07/27/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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