• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE EXCELSIOR; SYRINGE, 10ML SALINE IN 10ML

  • 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
 

MEDLINE EXCELSIOR; SYRINGE, 10ML SALINE IN 10ML Back to Search Results
Model Number EMZE010001
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/28/2020
Event Type  malfunction  
Manufacturer Narrative
It was reported that a pre-filled syringe detached from an iv when used for flushing and drawing back blood.No serious injury or adverse impact to a patient or to a user was originally reported.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.Samples of the syringe and the needleless connectors used at the reporting facility were returned for evaluation.Testing of samples concluded that when the syringe is fully engaged onto the needleless connector, no disconnection occurred.However, it was confirmed that disconnection may occur if the syringe is not fully engaged with the needleless connector.The root cause was determined to be the result of improper connection and use of the syringe as instructions for use clearly state the devices if "for iv flush only." in an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) on 22-jan-2024, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
 
Event Description
It was reported that a pre-filled syringe detached from an iv when used for flushing and drawing back blood.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of Device
SYRINGE, 10ML SALINE IN 10ML
Manufacturer (Section D)
MEDLINE EXCELSIOR
1933 heck drive
neptune NJ 07753 4428
Manufacturer Contact
nigel vilches
three lakes drive
northfield, IL 60093-2753
MDR Report Key18954336
MDR Text Key338349982
Report Number2027791-2024-00044
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/20/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberEMZE010001
Device Lot Number3136370
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 01/28/2020
Initial Date FDA Received03/21/2024
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
-
-