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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO COAXIAL HIGH FLOW TIP; LAVAGE, JET
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STRYKER INSTRUMENTS-PUERTO RICO COAXIAL HIGH FLOW TIP; LAVAGE, JET Back to Search Results
Catalog Number 0210014100
Medical Device Problem Code Delivered as Unsterile Product (1421)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/27/2018
Type of Reportable Event Malfunction
Event or Problem Description
It was reported by the customer that a foreign object was observed in the package.There was no impact to the patient and the procedure was successfully completed.
 
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a root cause could not be determined for the event.Not available for return.
 
Event or Problem Description
It was reported by the customer that a foreign object was observed in the package.There was no impact to the patient and the procedure was successfully completed.
 
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Brand Name
COAXIAL HIGH FLOW TIP
Common Device Name
LAVAGE, JET
Manufacturer (Section D)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo MI 00615
MDR Report Key7832601
Report Number0001811755-2018-01632
Device Sequence Number1980794
Product Code FQH
UDI-Device Identifier34546540861253
UDI-Public34546540861253
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 01/03/2019
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 Health Professional
Device Catalogue Number0210014100
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/01/2018
Supplement Date Received by Manufacturer12/06/2018
Initial Report FDA Received Date08/30/2018
Supplement Report FDA Received Date01/03/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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