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

Catalog Number 831061

Device Problems Device Markings/Labelling Problem (2911); Inaccurate Information (4051); Wrong Label (4073)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2023

Event Type  malfunction  

Manufacturer Narrative

Production records investigated for lot number 556611p.The testing showed no indication of abnormalities or malfunction at time of production.

Event Description

Mckesson inventory manager reports that item retail level packaging mix up.831061 shipping cases is labeled with 831361.Lot has not yet been identified.

Manufacturer Narrative

Production records investigated for lot number 556611p.The testing showed no indication of abnormalities or malfunction at time of production.

Event Description

Mckesson inventory manager reports that item retail level packaging mix up.831061 shipping cases is labeled with 831361.Lot has not yet been identified.

Manufacturer Narrative

Reference (b)(4) for updating the insulin needle, pen needle and safety pen needle packaging to improve visibility of item numbers and the ability to scan udi information during manufacturing process to prevent packaging mix-ups.

Event Description

Mckesson inventory manager reports that item retail level packaging mix up.831061 shipping cases is labeled with 831361.Lot has not yet been identified.

• Brand Name: EASYTOUCH
• Type of Device: PEN NEEDLE
• 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: 16818313
• MDR Text Key: 314048193
• Report Number: 3005798905-2023-03111
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 831061
• Device Lot Number: 556611P
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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