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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS KABI USA, LLC MEDICATION SYRINGE

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FRESENIUS KABI USA, LLC MEDICATION SYRINGE Back to Search Results
Catalog Number FK562887
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/25/2017
Event Type  malfunction  
Event Description
While the nurse was trying to retract the needle after administration of drug, the syringe broke and the needle came out. The rn taking care of this patient was not stuck with the needle. Anecdotally, we have other similar events with these syringes.
 
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Type of DeviceMEDICATION SYRINGE
Manufacturer (Section D)
FRESENIUS KABI USA, LLC
three corporate drive
lake zurich IL 60047
MDR Report Key7159666
MDR Text Key96227910
Report Number7159666
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 12/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/03/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberFK562887
Device Lot Number619779
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/28/2017
Event Location Hospital
Date Report to Manufacturer12/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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