MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC MEMBER'S MARK; INSULIN SYRINGE

Catalog Number 731365

Device Problems Material Deformation (2976); Material Integrity Problem (2978); Material Twisted/Bent (2981)

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

Event Date 03/01/2021

Event Type  malfunction  

Event Description

End user received insulin needles upon opening box.

Event Description

End user received bent insulin needles upon opening box.

Manufacturer Narrative

Production records investigated for lot number 50445.The testing showed no indication of abnormalities or malfunction at time of production.

• Brand Name: MEMBER'S MARK
• Type of Device: INSULIN 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: 11581754
• MDR Text Key: 242752128
• Report Number: 3005798905-2021-02987
• 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: Replace
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 731365
• Device Lot Number: 50445
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/01/2021
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Sex: Female