MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS LLC. EASY TOUCH; EASY TOUCH INSULIN SYRINGE

Model Number 829155

Device Problems Nonstandard Device (1420); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 03/08/2018

Event Type  malfunction  

Event Description

Product mislabel- item number 829155 lot 45014, et insulin syringe 29g 1cc 1/2" (b)(4) was contacted by a direct customer (distributor) regarding a labeling error regarding lot 45014.(b)(4) has found that the shipping case and inner package (poly bag) are labeled correctly however the are some retail shelf cartons that mislabeled with item# 829555 lot 45016.No injury was reported from the mislabel error.

• Brand Name: EASY TOUCH
• Type of Device: EASY TOUCH INSULIN SYRINGE
• 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 ; 8773584342
• MDR Report Key: 7405458
• MDR Text Key: 105257875
• Report Number: 3005798905-2018-00043
• 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: distributor
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 04/06/2018

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: Other
• Device Model Number: 829155
• Device Catalogue Number: 829155
• Device Lot Number: 45014
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2018
• Initial Date FDA Received: 04/06/2018
• 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: N
• Patient Sequence Number: 1