MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASYTOUCH INSULIN SYRINGE 31G-.5CC-5/16"; SYRINGE, PISTON

Model Number 831565

Device Problems Backflow (1064); Device Operational Issue (2914); Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/20/2017

Event Type  malfunction  

Event Description

User claimed that the insulin syringes were not working properly."they won't draw up any fluid or they get to certain amount of fluid drawn" and user would have to "pull and tug to get them filled".User said that multiple needles were bent and that three out of every ten syringes were defective.

• Brand Name: EASYTOUCH INSULIN SYRINGE 31G-.5CC-5/16"
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC; 11930 kemper springs drive; cincinnati OH 45240
• Manufacturer (Section G): MHC MEDICAL PRODUCTS, LLC.; 11930 kemper springs drive; cincinnati OH 45240
• Manufacturer Contact: jennifer seiple ; 11930 kemper springs drive; cincinnati, OH 45240
• MDR Report Key: 7600719
• MDR Text Key: 111043249
• Report Number: 3005798905-2018-02103
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/13/2018

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: Lay User/Patient
• Device Expiration Date: 04/02/2022
• Device Model Number: 831565
• Device Lot Number: 44306B, 40074B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2017
• Initial Date FDA Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: EASYTOUCH INSULIN SYRINGE 31G-.5CC-5/16" (831565)