MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASYTOUCH INSULIN SYRINGE 29G-.5CC-1/2"; SYRINGE, PISTON

Model Number 829555

Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975); Physical Property Issue (3008)

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

Event Date 01/04/2018

Event Type  malfunction  

Event Description

Customer reported the following problem: "i have ordered this product many times and have never had an issue.This time i ordered and simply had a round sticker as a seal.The sticker that says non-returnable if seal is broken was not on the product.Each of these bags were not only stacked different then typically, but there wasn't the small gap of air between the "plunger" and the top.Also the "plunger" was stuck to the top.Out of the first bag i have had 6 so far (now up to 10) since i originally sent this message to the company i order from that will not pull any insulin into them that i have just had to throw away.I have never had this issue and not sure what happened with this certain box i was shipped.If you could please inform me of any changes in the product (i was given one email that didn't work but was given this one today) but the whole box from what i can see inside of the bags are made the same.The item number is 829555.The ndc/hri# (b)(4)".

• Brand Name: EASYTOUCH INSULIN SYRINGE 29G-.5CC-1/2"
• 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: 7607798
• MDR Text Key: 111308726
• Report Number: 3005798905-2018-02292
• 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: 06/15/2018

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 Model Number: 829555
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/04/2018
• Initial Date FDA Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1