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

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problems Fever (1858); Chills (2191); Reaction (2414)

Event Date 11/13/2014

Event Type  Injury  

Event Description

We received the call on (b)(6) 2014 from mr.(b)(6), a registered pharmacist at (b)(6).He said, the patient got fever and chills within 20 mins of using our normal saline iv flush syringe.Adverse event(s): fever, chills.Reporter information: mr.(b)(6).Primary complainant (patient): ms.(b)(6).Age: (b)(4).(b)(6).

Manufacturer Narrative

(b)(6) year old diagnosed with a single pulmonary nodule on left lung.Sse had a picc line places for alternative iv therapy.Per patient, she experienced fever and chills after administration of medefil normal saline i.V.Flush syringe lot: s13409 on several occasions.Fever and chills resides after few hours and temperature returned to normal.Patient had been using medefil normal saline i.V.Flush syringe in the past.She returned this lot back to kroger pharmacy.Mr.(b)(6) informed provided us 13 syringes from the same lot which we received on (b)(4) 2014.Retain samples from the same lot were visually inspected and tested for bacterial endotoxins and sterility.Results were negative and no findings were revealed.Returned samples from the same lot received from mr.(b)(6) were visually inspected and tested for bacterial endotoxins.Results were negative and no findings were revealed.Sterility test is still in progress and no growth is found till today's date.The investigation is still in progress and the rest investigation details will be reported to the fda using a follow-up mdr.Retain device from same lot evaluated.

Manufacturer Narrative

(b)(6) old female diagnosed with a single pulmonary nodule on the left lung.She had a peripherally inserted central catheter (picc) line placed for alternative iv therapy.Per patient, she experienced fever and chills after administration of medefil's normal saline i.V.Flush syringe lot: s13409 on several occasions.Fever and chills resides after a few hours and temperature returned to normal.Patient has used medefil normal saline i.V.Flush syringe in the past.She returned this lot back to (b)(6) pharmacy.Mr.(b)(6) informed provided us 13 syringes from the same lot, which we received on 12/30/2014.Retain samples from the same lot were visually inspected and tested for bacterial endotoxins and sterility.Results were negative and no findings were revealed.Returned samples from the same lot received from mr.(b)(6) were visually inspected and tested for bacterial endotoxins and sterility.Results were negative and no findings were revealed.The batch production records for this lot were also reviewed, and no anomalies were noted during the manufacture of this batch.All initial, in - process, and final testing of the batch were acceptable.We also reviewed our product complaint - reporting database and there are no other complaints reported for this lot.We believe this occurrence is an isolated incident.This summary on our investigation and results were discussed with the complainant.Based on this investigation, we are closing the complaint and will be revisiting it if any additional information is available regarding this event.

Event Description

On (b)(6) 2014, we received the call from mr.(b)(6), a registered pharmacist at (b)(6) pharmacy.He stated that the patient reported that she had fever and chills within 20 mins of using our normal saline i.V.Flush syringe.Adverse event(s): fever, chills.(b)(6).Primary complainant (patient): ms.(b)(6).

• 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: 4406175
• MDR Text Key: 5307904
• Report Number: 1423982-2015-00001
• 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
• Reporter Occupation: Patient
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2015
• Device Model Number: N/A
• Device Catalogue Number: MIS 1133
• Device Lot Number: S13409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 53 YR