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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SYR W/NDLE,HYPODERM,TB,27GX 1/2", 1M

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MEDLINE INDUSTRIES, LP; SYR W/NDLE,HYPODERM,TB,27GX 1/2", 1M Back to Search Results
Model Number SYR101272H
Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/06/2023
Event Type  malfunction  
Manufacturer Narrative
It was reported that a needle detached from the syringe and medication leaked out.No serious injury or adverse impact to a patient or 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.No photo or sample were provided for evaluation.The reported problem/issue was unable to be confirmed and a root cause was unable to be determined.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 needle detached from the syringe and medication leaked out.
 
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Type of Device
SYR W/NDLE,HYPODERM,TB,27GX 1/2", 1M
Manufacturer (Section D)
MEDLINE INDUSTRIES, LP
three lakes drive
northfield IL 60093 2753
Manufacturer Contact
nigel vilches
three lakes drive
northfield, IL 60093-2753
MDR Report Key18960358
MDR Text Key338498518
Report Number1417592-2024-00182
Device Sequence Number1
Product Code FMF
UDI-Device Identifier10080196448814
UDI-Public10080196448814
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 03/22/2024
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 NumberSYR101272H
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/06/2023
Initial Date FDA Received03/22/2024
Was Device Evaluated by Manufacturer? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
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