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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 5F X 20CM DBL CT MIDLINE
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MEDICAL COMPONENTS, INC. 5F X 20CM DBL CT MIDLINE Back to Search Results
Model Number MLCT5D20
Device Problem Leak/Splash (1354)
Patient Problem Hematoma (1884)
Event Date 12/12/2019
Event Type  malfunction  
Manufacturer Narrative
Currently waiting for the device to be returned for evaluation.
 
Event Description
During power infusion, leakage in the subcutaneous tissue was noted.When the catheter was removed, a small crack was noted around 2cm from the hub.
 
Manufacturer Narrative
The 5f midline was returned for evaluation.Visual inspection of the device revealed a hole in the lumen approximately 0.3cm in length at the 4cm mark.The lumen also appears to "curve" at the 4cm mark.Medcomp engineering reviewed the device and confirmed that the lumen appears to have burst at the 4cm depth mark as a result of excessive pressure.The lumen stretched and burst.The manufacture records were reviewed and no non-conformances or variances were noted.Root cause cannot be determined.
 
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Brand Name
5F X 20CM DBL CT MIDLINE
Type of Device
CT MIDLINE
Manufacturer (Section D)
MEDICAL COMPONENTS, INC.
1499 delp drive
harleysville PA 19438
MDR Report Key9590526
MDR Text Key200663106
Report Number2518902-2019-00084
Device Sequence Number1
Product Code PND
UDI-Device Identifier00884908113754
UDI-Public884908113754
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 02/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/03/2021
Device Model NumberMLCT5D20
Device Catalogue NumberMLCT5D20
Device Lot NumberMNCJ240
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2020
Was the Report Sent to FDA? No
Date Manufacturer Received12/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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