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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 20CM CATHETER, PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 8.5FR X 20CM CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number CS-15853-E
Device Problem Migration (4003)
Patient Problems Pain (1994); No Known Impact Or Consequence To Patient (2692)
Event Date 01/11/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Potential lot numbers: 71f18j0107; 71f18g2108; 71f18g0036. It is unknown if the device is available for evaluation.

 
Event Description

It was reported that a catheter was inserted on friday (b)(6) 2019. The catheter had to be removed within the week end because of the pain encountered during infusions. When the nurse removed the catheter, she noticed that only 2 cm of the catheter were removed from the patient, thus the rest was still in the patient. Nevertheless, an x-ray was performed, and nothing was found. Additional information received indicates that the device did not break or rupture. It is reported that the doctor suggests that the small wings of the luer would have induced a rise of the distal part of the catheter and thus some pain for the patient.

 
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Brand NameARROW CVC SET: 3-LUMEN 8.5FR X 20CM
Type of DeviceCATHETER, PERCUTANEOUS
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 Key8296753
MDR Text Key134732899
Report Number3006425876-2019-00061
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberK862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/16/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/01/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberCS-15853-E
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 Received03/06/2019
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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