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

Catalog Number 730365

Device Problem Dull, Blunt (2407)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/07/2020

Event Type  malfunction  

Event Description

End-user called in reporting that the pen needles they are blunt.The end-user stated the, "needle are blunt" and that "the syringes had a hard time going through the insulin vial.".

Manufacturer Narrative

Trend analysis conducted on lot 45322.No trend was found when reviewing lot 45322.Production records for lot 45322 were analyzed.Upon analyzing the records there was no indication of malfunction or nonstandard products produced.

Event Description

End-user called in reporting that the pen needles they are blunt.The end-user stated the, "needle are blunt" and that "the syringes had a hard time going through the insulin vial.".

• Brand Name: MEMBER'S MARK
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC; 8695 seward road; fairfield OH 45011
• MDR Report Key: 10145743
• MDR Text Key: 195096848
• Report Number: 3005798905-2020-02950
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K102178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 730365
• Device Lot Number: 45322
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1