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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SYRINGE, 10ML SALINE IN 10ML
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MEDLINE INDUSTRIES, LP; SYRINGE, 10ML SALINE IN 10ML Back to Search Results
Catalog Number EMZE010001
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/12/2021
Event Type  malfunction  
Manufacturer Narrative
It was reported that the syringes "leak in package", "leak when being injected", and "crack under the label".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.Due to the reported problem/issue, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
 
Event Description
It was reported that the syringes "leak in package", "leak when being injected", and "crack under the label".
 
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Type of Device
SYRINGE, 10ML SALINE IN 10ML
Manufacturer (Section D)
MEDLINE INDUSTRIES, LP
three lakes drive
northfield IL 60093
Manufacturer Contact
danielle tognocchi
three lakes drive
northfield, IL 60093
MDR Report Key18783780
MDR Text Key337256986
Report Number2027791-2024-00005
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 Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 02/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberEMZE010001
Device Lot Number3139040
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2021
Date Manufacturer Received03/12/2021
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; Other;
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