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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDCOMP SPLIT STREAM CATHETER; HEMODIALYSIS CATHETER

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MEDCOMP SPLIT STREAM CATHETER; HEMODIALYSIS CATHETER Back to Search Results
Device Problems Air Leak (1008); Crack (1135); Hole In Material (1293)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/13/2014
Event Type  malfunction  
Event Description
Split stream catheter had bubbles found during dialysis.Cracked catheter and a hole found.Dialysis was stopped immediately.Pt was fine.
 
Manufacturer Narrative
An investigation has been initiated.We are currently waiting for the returned of the device sample for evaluation.When the investigation is complete a final report will be submitted.
 
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Brand Name
SPLIT STREAM CATHETER
Type of Device
HEMODIALYSIS CATHETER
Manufacturer (Section D)
MEDCOMP
harleysville PA
Manufacturer (Section G)
MEDCOMP
1499 delp dr.
harleysville PA 19438
Manufacturer Contact
susan smith, rn
1499 delp dr.
harleysville, PA 19438
2152564201
MDR Report Key4118844
MDR Text Key4795803
Report Number2518902-2014-00059
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeHK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 09/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/27/2014
Initial Date FDA Received09/22/2014
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;
Patient Age83 YR
Patient Weight51
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