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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAP SYRINGE, PISTON

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CAP SYRINGE, PISTON Back to Search Results
Device Problems Difficult to Remove (1528); Use of Device Problem (1670)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/20/2020
Event Type  malfunction  
Event Description
Single use caps on prefilled syringes can be removed without breaking them as designed allowing the cap to be reused. The syringe contents can be adulterated or diverted without detection. Fda safety report id# (b)(4).
 
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Brand NameCAP
Type of DeviceSYRINGE, PISTON
MDR Report Key10086855
MDR Text Key192206629
Report NumberMW5094668
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 Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/22/2020 Patient Sequence Number: 1
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