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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HOSPIRA SYRINGE, PISTON

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HOSPIRA SYRINGE, PISTON Back to Search Results
Lot Number 09-099-R1
Device Problems Crack (1135); Device Displays Incorrect Message (2591)
Patient Problem Insufficient Information (4580)
Event Date 08/03/2021
Event Type  malfunction  
Event Description
Pca machine beeped syringe error- checked syringe and the glass was cracked. Syringe, tubing, and machine changed.
 
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Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
HOSPIRA
375 n. field dr
lake forest IL 60045
MDR Report Key12445698
MDR Text Key270549743
Report Number12445698
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number09-099-R1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/30/2021
Event Location Hospital
Date Report to Manufacturer09/09/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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