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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TTLVENT 16FR10ML 100%SIL UM TR

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MEDLINE INDUSTRIES INC.; TTLVENT 16FR10ML 100%SIL UM TR Back to Search Results
Catalog Number URO180816
Device Problems Deflation Problem (1149); Device Dislodged or Dislocated (2923)
Patient Problem No Information (3190)
Event Date 04/04/2019
Event Type  Injury  
Manufacturer Narrative
It was reported that the foley catheter fell out of the patient partially deflated and caused unspecified trauma.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further patient, product, or incident details to the manufacturer.The sample was received in used, unpackaged condition.No issues or abnormalities were found during testing, including at the vent, tubing, or bag.The reported issue of a deflating balloon was not confirmed through evaluation of the received sample.Due to the reported incident and 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.
 
Event Description
It was reported that the foley catheter fell out of the patient partially deflated and caused unspecified trauma.
 
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Type of Device
TTLVENT 16FR10ML 100%SIL UM TR
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield IL 60093
Manufacturer Contact
karen trutsch
three lakes drive
northfield, IL 60093
8476434960
MDR Report Key8569045
MDR Text Key143696017
Report Number1417592-2019-00061
Device Sequence Number1
Product Code OHR
UDI-Device Identifier10889942687145
UDI-Public10889942687145
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberURO180816
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/09/2019
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/05/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? 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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