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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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Manufacturer (Section D)
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