MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASYTOUCH; SYRINGE

Catalog Number 827155

Device Problems Incomplete or Missing Packaging (2312); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

Patient Problem Laceration(s) (1946)

Event Date 02/14/2022

Event Type  malfunction  

Event Description

End user reported that a insulin syringe inside a sealed polybag from item number 827155 lot number 51382 expiration date 05/21/2025 was missing a cap and the syringe cap does not appear inside of the sealed polybag.User did get an unexpected poke by the exposed syringe cannula but is unaffected.

Manufacturer Narrative

Initial trend analysis and production records investigated for lot 51382 was conducted, no malfunctions were found.This is the only complaint for lot 51382.Further investigation will be conducted to determine the root cause of complaint.

Event Description

End user reported that a insulin syringe inside a sealed polybag from item number 827155, lot number 51382, expiration date 05/21/2025 was missing a cap and the syringe cap does not appear inside of the sealed polybag.User did get an unexpected poke by the exposed syringe cannula but is unaffected.

Manufacturer Narrative

Initial trend analysis and production records investigated for lot number 51382, no malfunctions were found.The packing process was investigated and due to the automatic packing preformed with use of a conveyor belt method, there is a occurrence that the needle cap will be stuck in the process of automatic bag packing, the likelihood of this happening has been reduced to 0.16%-0.01% after improvements to the conveyor in 2021.The manufacturer proposed to make continuous improvements to the conveyor packing method.

• Brand Name: EASYTOUCH
• Type of Device: SYRINGE
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield OH 45011
• Manufacturer (Section G): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield OH 45011
• Manufacturer Contact: troy smith ; 8695 seward road; fairfield, OH 45011
• MDR Report Key: 13725517
• MDR Text Key: 289104246
• Report Number: 3005798905-2022-03043
• 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: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 827155
• Device Lot Number: 51382
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/14/2022
• 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
• Patient Sequence Number: 1