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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDCOMP DOUBLE LUMEN INFUSION CATH SET; INFUSION CATHETER
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MEDCOMP DOUBLE LUMEN INFUSION CATH SET; INFUSION CATHETER Back to Search Results
Model Number MC2L-12S
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/08/2016
Event Type  malfunction  
Event Description
The guide wire broke at the end of the procedure, getting stuck in the catheter within the patient, requiring the removal and disposal of the material and the realization of new puncture.
 
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Brand Name
DOUBLE LUMEN INFUSION CATH SET
Type of Device
INFUSION CATHETER
Manufacturer (Section D)
MEDCOMP
1499 delp drive
harleysville PA 19438
Manufacturer (Section G)
MEDCOMP
1499 delp drive
harleysville PA 19438
Manufacturer Contact
1499 delp drive
harleysville, PA 19438
2152564201
MDR Report Key6118202
MDR Text Key60874202
Report Number2518902-2016-00039
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Other
Type of Report Initial
Report Date 11/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/04/2019
Device Model NumberMC2L-12S
Device Catalogue NumberMC2L-12S
Device Lot NumberMBSP050
Other Device ID Number884908028072
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received10/24/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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