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

Catalog Number 627155 OR 628155 OR 627555

Device Problems Detachment Of Device Component (1104); Physical Property Issue (3008)

Patient Problems Abscess (1690); Bacterial Infection (1735); Patient Problem/Medical Problem (2688)

Event Date 04/09/2018

Event Type  Injury  

Manufacturer Narrative

It was disclosed to the manufacturer that it is unknown if the device was used for its intended use to admisiter insulin.Mhc has been given minimal information and no specific lot or item number was provided however several lot numbers and item numbers were sighted by the complainant the complaint came from a needle exchange unit.The patient is ananymous and limited informaiton was provided to mhc regarding the incident.

Event Description

Needle disengaged from syringe while sill in arm needle was removed abcess later developed and user went to the hospital for treatment and recovered.

• 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: 7636572
• MDR Text Key: 112271015
• Report Number: 3005798905-2018-00986
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K102178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Risk Manager
• 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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 627155 OR 628155 OR 627555
• Device Lot Number: 37801, 37803, 41795, 47601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1