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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 2-LUMEN 7FR X 20CM ADULT MULTI LUMEN CATHETER PRODUCTS

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ARROW INTERNATIONAL INC. CVC SET: 2-LUMEN 7FR X 20CM ADULT MULTI LUMEN CATHETER PRODUCTS Back to Search Results
Catalog Number SA-17702-J
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Fever (1858)
Event Date 05/24/2015
Event Type  Malfunction  
Event Description

It was reported that during a three-month placement of a telelex-made double-lumen, 7fr, 20cm catheter in the patient's left internal jugular vein, the patient presented symptoms similar to "catheter fever"/catheter related infection and as a result, the catheter was removed and replaced. The md commented the fever was not due to the catheter and it was due to their hospital handling issue. Although the patient's fever was solved after replacing the catheter but we don't have an exact answer whether the fever was because of catheter infection.

 
Manufacturer Narrative

Qn#(b)(4). Additional information: this product is not sold in the us. The 510k # provided is for a similar product that is sold in the us. This report is for the first in a series of product issues with the same patient. The second event has been reported under mdr#3006425876-2015-00188.

 
Manufacturer Narrative

(b)(4). Additional information: complaint verification testing could not be performed because no sample was returned for evaluation. A review of manufacturing records did not yield any relevant findings. The report was reviewed, but no cause could be determined from the information provided and without a sample. No further action will be taken.

 
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Brand NameCVC SET: 2-LUMEN 7FR X 20CM
Type of DeviceADULT MULTI LUMEN CATHETER PRODUCTS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA 0000
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 0000 591
EZ 0000591 0
Manufacturer Contact
john george
2400 bernville road
reading, PA 19605-0000
6103780131
MDR Report Key4824252
MDR Text Key19984741
Report Number3006425876-2015-00187
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/27/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/05/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2016
Device Catalogue NumberSA-17702-J
Device LOT Number71F14H1359
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/10/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/26/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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