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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PREFILLED SALINE FLUSH SYRINGE

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PREFILLED SALINE FLUSH SYRINGE Back to Search Results
Event Type  Malfunction  
Event Description

Ismp medication errors reporting program. Access number: (b)(4). Actual error: no. Description: could the topic of unsafe practices with prefilled saline flush syringes be re-visited? despite education efforts, we are continuing to see wide spread unsafe use of this product by healthcare professionals throughout the country. The mfrs should also take some responsibility on labeling the syringes with strict use instructions/safety warnings in addition to not placing the syringe on a sterile field (e. G. Syringe is not sterile - do not pull back on plunger: for saline flush use only - do not re-label syringe, do not use for reconstituting, dilution or administration of medications). The pt safety created by using prefilled saline flush syringes is under serious attack by the unsafe practice creating sterility issues with medication preparation/administration. A clear single message should be given to healthcare professionals concerning saline flush syringes: never use for medication: dilution, mixing, reconstitution, or administration (syringe should never be re-labeled). Thank you for your consideration. Medication not administered to or used by the pt. Ismp, (b)(4).

 
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Brand NameUnknown Brand Name
Type of DevicePREFILLED SALINE FLUSH SYRINGE
MDR Report Key2501052
Report NumberMW5024714
Device Sequence Number1
Product CodeNGT
Report Source Voluntary
Type of Report Initial
Report Date 01/23/2012
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/20/2012
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER

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