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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; SYRINGE,IRRIGATION,BULB,60ML,STERILE

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MEDLINE INDUSTRIES LP; SYRINGE,IRRIGATION,BULB,60ML,STERILE Back to Search Results
Catalog Number DYND20125H
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2024
Event Type  malfunction  
Manufacturer Narrative
According to the customer, on 02/01/2024 when opening the bulb syringe packaging a "hair" was noted to be "in the syringe".The customer reported there was no patient involvement, and a new bulb syringe was obtained.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.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 for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
 
Event Description
According to the customer, on (b)(6) 2024 when opening the bulb syringe packaging a "hair" was noted to be "in the syringe".
 
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Type of Device
SYRINGE,IRRIGATION,BULB,60ML,STERILE
Manufacturer (Section D)
MEDLINE INDUSTRIES LP
three lakes drive
northfield IL 60093
Manufacturer Contact
danielle tognocchi
three lakes drive
northfield, IL 60093
MDR Report Key18847919
MDR Text Key337256977
Report Number1417592-2024-00309
Device Sequence Number1
Product Code KYZ
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 03/06/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/06/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberDYND20125H
Device Lot Number96922120002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/19/2024
Date Manufacturer Received02/09/2024
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;
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