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U.S. Department of Health and Human Services

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

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MEDLINE EXCELSIOR; SYRINGE, 10ML SALINE IN 10ML Back to Search Results
Model Number EMZE010001
Device Problems Crack (1135); Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/12/2020
Event Type  malfunction  
Event Description
It was reported that a pre-filled syringes were found to have leaked within their packaging.
 
Manufacturer Narrative
It was reported that a pre-filled syringes were found to have leaked within their packaging.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.A sample was returned for evaluation and it was confirmed to have a cracked barrel and a tear in the overwrap packaging.Retention samples were evaluated with no similar problem/issue identified.It is likely that the cracked syringe was caused by low temperatures experienced by the syringe during or after shipment.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
 
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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 Key18954405
MDR Text Key339211450
Report Number2027791-2024-00045
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 Number3137114
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 02/12/2020
Initial Date FDA Received03/21/2024
Was Device Evaluated by Manufacturer? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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