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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 5 FR X 13 CM CATHETER, PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 5 FR X 13 CM CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number CS-14502
Device Problems Crack (1135); Leak/Splash (1354)
Patient Problems Pain (1994); Swelling (2091); No Known Impact Or Consequence To Patient (2692)
Event Date 03/19/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). Potential lot numbers reported: 71f17l2976, 71f17j1717, 71f17j1531.

 
Event Description

The customer reports: transfusion installed on the catheter following blood test and positive pression rinse with saline solution. After 45 minutes, the child complains of pain and inflation on the neck. The transfusion is stopped, 20 ml are removed from the catheter, the vitals are good. The child had an x-ray and an ultrasound: the catheter is cracked. The child got in the operating room in the afternoon so that the catheter is removed. Additional information: the catheter was removed and successfully replaced. The patient is fine.

 
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Brand NameARROW CVC SET: 2-LUMEN 5 FR X 13 CM
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 Key7480900
MDR Text Key107153215
Report Number3006425876-2018-00274
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation PHARMACIST
Type of Report Initial,Followup
Report Date 04/18/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/02/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberCS-14502
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/04/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2018
Was Device Evaluated By Manufacturer? Yes
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: 05/02/2018 Patient Sequence Number: 1
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