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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTL., INC. HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; ACUTE HEMODIALYSIS CATHETER PRODUCTS
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ARROW INTL., INC. HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; ACUTE HEMODIALYSIS CATHETER PRODUCTS Back to Search Results
Catalog Number CS-15122-F
Device Problem Kinked (1339)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/11/2014
Event Type  malfunction  
Event Description
It was reported that during insertion in general medicine, the swg kinked when inserted into the dilator.As a result, a new kit was opened and used to successfully complete the procedure.A delay was reported, however, there was no additional harm to the patient due to this delay or as a result of this occurrence.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 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
alice harper
2400 bernville rd.
reading, PA 19605
6103780131
MDR Report Key4308388
MDR Text Key5134711
Report Number1036844-2014-00471
Device Sequence Number1
Product Code LFJ
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K895417
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 11/12/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/29/2016
Device Catalogue NumberCS-15122-F
Device Lot Number23F14B0787
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/14/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/12/2014
Initial Date FDA Received11/20/2014
Was Device Evaluated by Manufacturer? No
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
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