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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5FR X 20CM CATHETER, INTRAVASCULAR, THERAPEUTIC

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ARROW INTERNATIONAL INC. ARROW CVC SET: 4-LUMEN 8.5FR X 20CM CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Catalog Number EU-15854-CVT
Device Problem Migration or Expulsion of Device (1395)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)
Event Date 10/01/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Complaint verification testing could not be performed as no sample was returned for analysis. A device history record review could not be performed since a correct lot number was not provided by the customer. Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information. Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
The customer alleges repeated dislocation of the cvc from the fixing clamp despite correct fixation.
 
Manufacturer Narrative
(b)(4). The device product is not intended for sale in the us. Similar device product sold in the us. It is unknown, at the time of this report, if the device sample is available for evaluation.
 
Event Description
The customer alleges repeated dislocation of the cvc from the fixing clamp despite correct fixation.
 
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Brand NameARROW CVC SET: 4-LUMEN 8.5FR X 20CM
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ 591 01
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key6990014
MDR Text Key161886259
Report Number3006425876-2017-00477
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/31/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEU-15854-CVT
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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