MAUDE Adverse Event Report: PREFILLED SALINE FLUSH SYRINGE

Device Problem Inadequate Instructions for Healthcare Professional (1319)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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).

• Brand Name: Unknown Brand Name
• Type of Device: PREFILLED SALINE FLUSH SYRINGE
• MDR Report Key: 2501052
• MDR Text Key: 2574786
• Report Number: MW5024714
• Device Sequence Number: 1
• Product Code: NGT

Combination Product (Y/N)

• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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 Received: 03/20/2012
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: OTHER