MAUDE Adverse Event Report: MHC MEDICAL PRODCUTS, LLC. EASY TOUCH INSULIN SYRINGE

Catalog Number 827555

Device Problem Detachment Of Device Component (1104)

Patient Problem No Code Available (3191)

Event Date 03/09/2018

Event Type  malfunction  

Event Description

Had problems with the syringes. In the last week customer had experienced (4) faulty syringes; as she was injecting the syringe, the tip detached from the unit, leaving the point/metal part in her skin. This has caused the over use of medicine. Customer wanted to know how to she can save the medicine or what she can do.

• Brand Name: EASY TOUCH
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): MHC MEDICAL PRODCUTS, LLC.; 11930 kemper springs drive; cincinnati OH 45240
• Manufacturer (Section G): MHC MEDICAL PRODCUTS, LLC.; 11930 kemper springs drive; cincinnati OH 45240
• Manufacturer Contact: jennifer seiple ; 11930 kemper springs drive; cincinnati, OH 45240
• MDR Report Key: 7636570
• Report Number: 3005798905-2018-00977
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer

Reporter Occupation

• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 827555
• Device Lot Number: 44191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial