MAUDE Adverse Event Report: MEDEFIL, INC. NORMAL SALINE I. V. FLUSH SYRINGE

Catalog Number MIS-1130

Device Problem Insufficient Information (3190)

Patient Problems Nausea (1970); Vomiting (2144)

Event Date 08/12/2014

Event Type  Injury  

Event Description

Patient reports metallic taste and nausea after iv flush with medefil normal saline i.V.Flush syringe.10ml in 12ml syringe, ndc (b)(4).Potential lot number: s14313?may 2016.Upon using regular normal saline (hospira) iv vials preservative free, patient did not have similar reaction.Patient experiences nausea with vomiting after receiving immediately from prefilled syringe with normal saline.No problem with give/normal saline from vials.Event abated after use stopped or dose reduces: yes.

Manufacturer Narrative

Contact information for initial reporter is not available.This event was investigated under customer complaint.Batch record revealed no observation leading to this complaint.Retain samples were tested for this lot, results were within the specification.(b)(4).No similar complaint were received for this lot in the past.This complaint investigation will be revisited if the additional information is available.Device not available for evaluation.

• Brand Name: NORMAL SALINE I. V. FLUSH SYRINGE
• Type of Device: NORMAL SALINE I. V. FLUSH SYRINGE
• Manufacturer (Section D): MEDEFIL, INC.; 250 windy point drive; glendale heights IL 60139
• Manufacturer (Section G): MEDEFIL, INC.; 250 windy point drive; glendale heights IL 60139
• Manufacturer Contact: krupal rewanwar ; 250 windy point drive; glendale heights, IL 60139 ; 6306824600
• MDR Report Key: 4579530
• MDR Text Key: 5336734
• Report Number: 1423982-2015-00002
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: K091583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/06/2015

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 Catalogue Number: MIS-1130
• Device Lot Number: S14313
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2015
• Initial Date FDA Received: 03/07/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/10/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other