MAUDE Adverse Event Report: MEDEFIL INC. NORMAL SALINE I.V. FLUSH SYRINGE, 0.9% NACL, PRESERVATIVE FREE; NORMAL SALINE I.V. FLUSH SYRINGE, PRESERVATIVE FREE

Model Number 64253-0111-30

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nausea (1970); Vomiting (2144)

Event Date 08/12/2014

Event Type  Injury  

Event Description

Patient reports metalic taste and nausea after iv flush with normal saline preservative flush.Medefil inc, (b)(4) normal saline i.V.Flush syringe 10ml fill with 12ml syringe ll rx only.Ndc 64253-0111-30.Potential lot # s14313/may 2016.Upon using regular normal saline (hospira) iv vials preservative free, patient did not have similar reaction.Pt experiences nausea with vomiting after receiving immediately from pre filled syringe with normal saline.No problem with give/normal saline from vials.Event abated after use stopped or dose reduced: yes.

• Brand Name: NORMAL SALINE I.V. FLUSH SYRINGE, 0.9% NACL, PRESERVATIVE FREE
• Type of Device: NORMAL SALINE I.V. FLUSH SYRINGE, PRESERVATIVE FREE
• Manufacturer (Section D): MEDEFIL INC.; glendale heights IL 60139
• MDR Report Key: 4046875
• MDR Text Key: 4810232
• Report Number: MW5037944
• Device Sequence Number: 1
• Product Code: NGT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2016
• Device Model Number: 64253-0111-30
• Device Lot Number: POTENTIAL: S14313
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/15/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR