MAUDE Adverse Event Report: MEDIFIL INC HEPARIN IV FLUSH SYRINGE 50 UNITS/5 ML

Lot Number H15320N

Device Problem Packaging Problem (3007)

Patient Problem No Information (3190)

Event Date 10/07/2015

Event Type  malfunction  

Event Description

Heparin iv flush 50 units/5 ml was removed from automatic dispensing cabinet by nurse.Syringe is lacking all labeling.Just a plain syringe with overwrap still intact.Contains clear liquid, but amount and product are not discernable.Noticed by nurse, flush was quarantined and returned to pharmacy.The rest of the flushes were checked and are labeled correctly.

• Brand Name: HEPARIN IV FLUSH SYRINGE 50 UNITS/5 ML
• Type of Device: HEPARIN IV FLUSH SYRINGE 50 UNITS/5 ML
• Manufacturer (Section D): MEDIFIL INC; glendale heights IL
• MDR Report Key: 5155824
• MDR Text Key: 28572778
• Report Number: MW5057055
• Device Sequence Number: 1
• Product Code: NZW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2017
• Device Lot Number: H15320N
• Other Device ID Number: 64253-0222-35
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1