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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMS LIMITED MORPHINE SULFATE INJECTION, USP SYRINGE, PISTON

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IMS LIMITED MORPHINE SULFATE INJECTION, USP SYRINGE, PISTON Back to Search Results
Lot Number L1090H0
Device Problems Crack (1135); Leak/Splash (1354); Device Fell (4014)
Patient Problem Insufficient Information (4580)
Event Date 06/17/2021
Event Type  malfunction  
Event Description
Patient-controlled analgesia (pca) syringe was dropped while in box. Appeared intact except for a chip out of inner barrel below level of use. Nurse attached syringe to pump and iv tubing per policy. Patient required increasingly higher doses of pain medication. When syringe was removed from pump, it was noted that the inner barrel with had multiple cracks and medication inside was on the outer plastic barrel.
 
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Brand NameMORPHINE SULFATE INJECTION, USP
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
IMS LIMITED
886 santa anita ave
south el monte CA 91733
MDR Report Key12480464
MDR Text Key271662763
Report Number12480464
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 09/02/2021,06/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot NumberL1090H0
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/02/2021
Event Location Hospital
Date Report to Manufacturer09/16/2021
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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