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

Model Number MIS1130

Device Problem Sticking (1597)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Mewdefil qa has completed its review of the batch record for lot# s17151 and the summary is provided below: the normal saline i.V.Flush syringe, lot#s17151 was manufactured on 2/10/2017.(two) 2 lots of 12 cc barrels were used to manufacture this production lot.There was one report listing for discovery of barrels with "black specs".This is reflected in the recorded rejection of 6000 barrels.Replacement barrels came from the same lot as the other used barrels.Plunger stoppers came from 4 sub-lots but all of these lots were received on the same delivery.There no reported issues with the stoppers.Sterilization was executed without exception.Inventory usage was checked and no additional barrels or stoppers were issued to this lot (no indication of other unreported failures) there is no indication of a fault or failure that would have contributed to the reported complaint "plunger stuck".

Event Description

**actual ndc reported: (b)(4).** pt reported that when she pushed the plunger of the 5 ml normal saline flush syringe, often-times it would "stick" and when it released with further gentle pressure, it would push enough saline through the syringe to "blow" her vein.She has small veins and uses a small butterfly needle.She said she does try to "loosen" the syringe plunger ahead of time by push and pulling it thru the barrel but it still has a tendency to "stick" making it difficult to slowly or gently start the flushing.

• 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 60139
• Manufacturer (Section G): MEDEFIL, INC; 250 windy point drive; glendale heights 60139
• Manufacturer Contact: pradeep aggarwal ; 250 windy point drive; glendale heights 60139 ; 6306824600
• MDR Report Key: 6663410
• MDR Text Key: 78465211
• Report Number: 1423982-2017-00002
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 10364253111300
• UDI-Public: 0110364253111300
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020999
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/31/2019
• Device Model Number: MIS1130
• Device Lot Number: S17151
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other