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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; ADDITIONAL CATHETER INSERTION

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MEDLINE INDUSTRIES LP; ADDITIONAL CATHETER INSERTION Back to Search Results
Catalog Number UROT1098
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/09/2024
Event Type  malfunction  
Event Description
Leaking sample port.
 
Manufacturer Narrative
It was reported by the customer that on (b)(6) 2024, there was a "leaking sample port".It was reported that due to this, the catheter was removed and replaced.No harm to the patient was reported.A sample was requested to be returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
 
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Type of Device
ADDITIONAL CATHETER INSERTION
Manufacturer (Section D)
MEDLINE INDUSTRIES LP
three lakes drive
northfield IL 60093
Manufacturer Contact
kelly zampella
three lakes drive
northfield, IL 60093
MDR Report Key18630437
MDR Text Key335237067
Report Number1417592-2024-00048
Device Sequence Number1
Product Code OHR
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 02/02/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/02/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Catalogue NumberUROT1098
Device Lot Number23HBD476
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2024
Date Manufacturer Received01/09/2024
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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