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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTL., INC. HEMODIALYSIS KIT: 2-L 15 FR X 19 CM; ACUTE HEMODIALYSIS CATHETER PRODUCTS
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ARROW INTL., INC. HEMODIALYSIS KIT: 2-L 15 FR X 19 CM; ACUTE HEMODIALYSIS CATHETER PRODUCTS Back to Search Results
Catalog Number CS-15242-SP
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/04/2014
Event Type  malfunction  
Event Description
It is reported this event occurred in the dialysis department.The insertion site was the jugular vein.During dialysis, the physician found a crack in the clamp.The catheter had been in use for one year.As a result, a new catheter was placed successfully.There was placed successfully.There was no reported delay in treatment.There was no reported patient injury, complication, or death.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
HEMODIALYSIS KIT: 2-L 15 FR X 19 CM
Type of Device
ACUTE HEMODIALYSIS CATHETER PRODUCTS
Manufacturer (Section D)
ARROW INTL., INC.
reading PA
Manufacturer (Section G)
ARROW INTL., INC.
312 commerce pl.
asheboro NC 27203
Manufacturer Contact
john george
2400 bernville rd.
reading, PA 19605
MDR Report Key4347245
MDR Text Key5141643
Report Number1036844-2014-00503
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K111117
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 12/01/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCS-15242-SP
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/01/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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