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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW VASCULAR UNKNOWN DUMMY MATERIAL CATHETER, PERCUTANEOUS

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ARROW INTERNATIONAL INC. ARROW VASCULAR UNKNOWN DUMMY MATERIAL CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number VASCULAR UNKNOWN
Device Problem Migration (4003)
Patient Problems Fever (1858); Necrosis (1971); Sepsis (2067)
Event Date 07/18/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). Additional information received: the customer reports the device was in place for six days. After six days the catheter migrated. The patient condition is reported as "critical". The customer cannot rule out if the critical condition was contributed to the reported issue. Tissue necrosis (hand-size) was detected. Currently the necrosis is being treated with necrosis patch. Patient has sepsis. It is unknown if the device is available for evaluation.

 
Event Description

Customer reported that "cvc slipped through the box clamp (transparent-blue) that the cvc migrated out of patient until 1 cm".

 
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Brand NameARROW VASCULAR UNKNOWN DUMMY MATERIAL
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key8869852
MDR Text Key153545010
Report Number1036844-2019-00877
Device Sequence Number1
Product Code DQY
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 OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 07/24/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/07/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberVASCULAR UNKNOWN
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 Received09/09/2019
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

Patient TREATMENT DATA
Date Received: 08/07/2019 Patient Sequence Number: 1
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