Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC MEMBERS MARK; SYRINGE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MHC MEDICAL PRODUCTS, LLC MEMBERS MARK; SYRINGE Back to Search Results
Catalog Number 730365
Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/30/2021
Event Type  malfunction  
Manufacturer Narrative
When initial trend analysis for lot number 51391 was conducted there were no other complaints for lot number 51391.Additional investigation will be conducted for root cause of complaint.
 
Event Description
End user reports that the units marked on a barrel of one syringe in a box of one hundred are difficult to read.This caused complication in insulin dosage.
 
Manufacturer Narrative
Retained lot number 51391 was inspected for printing scale analysis to find that due to human error the final check of the syringes cannot be completely eliminated.Due to defects, training and equipment will be changed to improve quality of syringes.
 
Event Description
End user reports that the units marked on a barrel of one syringe in a box of one hundred are difficult to read.This caused complication in insulin dosage.
 
Manufacturer Narrative
Lot number 51391 production record were investigated.The graduation lines sampling performation test showed no indication of abnormality at time of production.
 
Event Description
End user reports that the units marked on a barrel of one syringe in a box of one hundred are difficult to read.This caused complication in insulin dosage.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MEMBERS MARK
Type of Device
SYRINGE
Manufacturer (Section D)
MHC MEDICAL PRODUCTS, LLC
8695 seward road
fairfield OH 45011
MDR Report Key11774473
MDR Text Key249457091
Report Number3005798905-2021-03005
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K102178
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Remedial Action Replace
Type of Report Initial,Followup,Followup
Report Date 04/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number730365
Device Lot Number51391
Date Manufacturer Received04/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-