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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 5.5FR X 13CM CATHETER, INTRAVASCULAR, THERAPEUTIC

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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 5.5FR X 13CM CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Model Number IPN030821
Device Problems Difficult to Flush (1251); Obstruction of Flow (2423)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/01/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint is reported as: "we have been having problems recently with the arrowg+ard blue 5fr 13 cm cvcs. They malfunction within 2-6 days, in that we can first no longer aspirate through the lumens, followed soon by being unable to flush through them as well. " it was reported the issue was resolved by replacing line with "pvcs or midline or another cvc". No patient harm reported.
 
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Brand NameARROW CVC SET: 3-LUMEN 5.5FR X 13CM
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 Key10697135
MDR Text Key211882664
Report Number3006425876-2020-00890
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUK
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 09/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/15/2021
Device Model NumberIPN030821
Device Catalogue NumberCS-26553
Device Lot Number71F19K2680
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 Received11/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/31/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/19/2020 Patient Sequence Number: 1
Treatment
NONE REPORTED.
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