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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. SPLIT CATH III; CATHETER, HEMODIALYSIS, IMPLANTED
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MEDICAL COMPONENTS, INC. SPLIT CATH III; CATHETER, HEMODIALYSIS, IMPLANTED Back to Search Results
Lot Number MNPC170
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/12/2019
Event Type  malfunction  
Event Description
After placing catheter in the patient, the nurse went to block catheter with heparin she noticed that one port said 2.0 and the other port also said 2.0 , usually one port is 2.0 and the other is 1.9.Catheter blocked according to the values listed on the catheter.We checked our other 32cm catheters, 4 within that same lot number and 5 in other lot numbers and all of the port values were listed as 2.0 and 1.9.I contacted medcomp to inquire about the discrepancy and follow up with medcomp is in process.Manufacturer response for 14 fx32cmsplit cath iii, (brand not provided) (per site reporter).Notified by interventional radiology director.
 
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Brand Name
SPLIT CATH III
Type of Device
CATHETER, HEMODIALYSIS, IMPLANTED
Manufacturer (Section D)
MEDICAL COMPONENTS, INC.
1499 delp drive
harleysville PA 19438
MDR Report Key9197499
MDR Text Key162517449
Report Number9197499
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 09/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Lot NumberMNPC170
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/16/2019
Event Location Hospital
Date Report to Manufacturer10/16/2019
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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