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

Catalog Number MIS 1135

Device Problem Insufficient Information (3190)

Patient Problems Fever (1858); Chills (2191)

Event Date 10/24/2014

Event Type  Injury  

Event Description

We received the email concerning this aer from baxter bioscience on 11/03/2014: "an adverse event report was received by the global pharmacovigilance department at the baxter healthcare corporation, in which your product saline flush and heparin flush was listed as a suspect drug.Adverse event(s): fever, chills.(b)(6).No additional information was provided.If you require additional information, please contact the reporter directly.".

Manufacturer Narrative

(b)(4).(b)(6).We received this complaint for two of our products (normal saline iv flush syringe and heparin iv flush syringe).According to the initial reporter, during a treatment to the patient, the nurse used advate as an anti-hemophilic treatment from baxter; with our products as concomitants.Therefore, an mdr will be filed for each of these two products.The complainant informed us that the actual samples are not available to return to us for evaluation, but she promised that she will send us some samples from the same lot.Retain samples from the same lot were visually inspected and tested for bacterial endotoxins.Results were negative and no findings were revealed.Further information received from the initial reporter: on (b)(6) 2014, when the patient received advate as an anti-hemophilic treatment from baxter; with our products as concomitants, the patient got the reaction.Reaction occurred within 20 minutes of infusion.Therefore, he was admitted to emergency shortly after reaction and also released from emergency on the same day.The symptoms experienced are not expected for this condition/therapy.Symptoms included fever up to 104 degrees f, shaking chills, hallucinations, and mental status changes.Patient has been on current therapy 1-6 months.The product was infused by a home care rn the investigation is still in progress and will be reported to the fda using a follow-up report.Device not yet received.

Manufacturer Narrative

Inadvertently put incorrect "date of this report".The previous report was submitted on 11/12/2014 instead of 11/07/2014.

Event Description

We received the email concerning this aer from baxter bioscience on 11/03/2014: "an adverse event report was received by the global pharmacovigilance department at the baxter healthcare corporation, in which your product saline flush and heparin flush was listed as a suspect drug.Adverse event(s): fever, chills.Reporter information: (b)(4).Patient information: pt identifiers: not available dob: (b)(6) 2011.No additional information was provided.If you require additional information, please contact the reporter directly.".

Manufacturer Narrative

On monday (b)(6) 2014, we received an update from the initial reporter, ms (b)(6), product coordinator at hemophilia center of western new york, in which she states: ".We have concluded that the adverse reaction was due to the advate.There was no reaction from the saline or heparin flushes provided by your company.Thank you for your involvement with the closure of this event." as a result of this new information and medefil internal complaint investigation, we are closing the complaint and sending this mdr closing report.The additional information confirms that the medefil products were not the causative agent of this adverse event.The complaint will be revisited, if additional information is received from the complainant.

Event Description

We received the email concerning this aer from baxter bioscience on (b)(6) 2014: "an adverse event report was received by the global pharmacovigilance department at the baxter healthcare corporation, in which your product saline flush and heparin flush was listed as a suspect drug.Adverse event(s): fever, chills.Reporter information: (b)(6).Patient information: pt identifiers: not available (b)(6).No additional information was provided.If you require additional information, please contact the reporter directly.".

• Brand Name: NORMAL SALINE IV FLUSH SYRINGE
• Type of Device: NORMAL SALINE IV 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: 4237623
• MDR Text Key: 4997759
• Report Number: 1423982-2014-00002
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091583
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Expiration Date: 07/31/2016
• Device Catalogue Number: MIS 1135
• Device Lot Number: S14400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ADVATE BY BAXTER; HEPARIN IV FLUSH SYRINGE BY MEDEFIL
• Patient Outcome(s): Hospitalization
• Patient Age: 4 YR