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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/15/2022

Event Type  malfunction  

Manufacturer Narrative

The black material was found adhered on the inner surface of the syringe barrel.Increased in-process manufacturing visual inspection and qa manual inspection has not resulted in any finding of product syringes containing black material.The additional manual inspection process has not found any syringe with black plunger stopper material defects as of 09/13/2022 or a total of 15 batches.Verbal instruction was provided to the medefil manufacturing and quality personnel for awareness and increased surveillance through manual inspection.Medefil will continue to monitor next production run on continuous basis.As corrective action at datwyler (vendor), awareness training was provided to the operators and updated molding startup inspections forms at datwyler site.A walk-through was conducted on 08/24/2022 in the production area to ensure all updated forms posted at molding stations at datwyler site.Retain sample analysis by qa, qc testing results verification, additional manual visual inspection, and routine qa visual inspection performed, and no similar defects were observed.After the investigation by the datwyler (vendor) at their site, datwyler found that the defect was confirmed to be trim debris from overflow of the molded sheet.Root cause is material.Root cause analysis, corrective action and preventive action were performed at vendor site.The product with black material adhered to the barrel surface, would not dislodge under agitation or product dispensing and, if the black material would dislodge from barrel surface, it would not dispense through the syringe luer lock tip opening.The black material was found to be the same material as plunger stopper therefore there is no product compatibility concern.

Event Description

On aug 15, 2022, medefil inc.Received email from reporter (b)(6) pharmacy) regarding unknown black material.It was mentioned in the email that a patient of them reported a pre-filled saline to have a piece of unknown black material floating around inside the syringe.Reporter attached photos of the syringe lot number: lot#: s21360/exp: 2023-10 with the email.Complaint sample was received at medefil, inc on (b)(6) 2022 and found that the black material was adhered to the inner surface of the barrel.It was not a floating material.

• Brand Name: NORMAL SALINE I.V. FLUSH SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): MEDEFIL, INC.; 250 windy point dr; glendale heights IL 60139 3805
• Manufacturer (Section G): MEDEFIL, INC.; 250 windy point dr; glendale heights IL 60139 3805
• Manufacturer Contact: pradeep aggarwal ; 250 widny point dr; glendale heights, IL 60139-3805 ; 6306824600
• MDR Report Key: 15620776
• MDR Text Key: 307072247
• Report Number: 1423982-2022-00006
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 6425311130
• UDI-Public: 64253-111-30
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091583
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: MIS-1130
• Device Lot Number: S21360
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1