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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB CATHETER INTRAVASCULAR THERAPE

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ARROW INTERNATIONAL INC. ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB CATHETER INTRAVASCULAR THERAPE Back to Search Results
Model Number IPN035619
Device Problem Obstruction of Flow (2423)
Patient Problem Extravasation (1842)
Event Date 02/08/2021
Event Type  Injury  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
The complaint is reported as: the nurse noted swelling on the patient's right side of the neck and shoulder and notified the physician. The physician recommended monitoring of site. Patient noted to have hypotension despite being on pressors and worsening swelling and reddish discoloration of skin. The physician was notified, but no orders were given. The central line was then reported to be clotted and unable to infuse the pressors. The patient's systolic blood pressure was reported to be 90. The pressors were switch to the patient's port-a-cath and the systolic blood pressure increased suddenly to the 200s. Epinephrine and neosynephrine were stopped. The user tried to draw back from the catheter but was unable to. The physician was informed and extravasation suspected. A chest x-ray was performed and the patient was treated with terbutaline. A new central line was inserted in the left ij and the right sc central line was discontinued. The patient's condition was reported to be fine.
 
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Brand NameARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB
Type of DeviceCATHETER INTRAVASCULAR THERAPE
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
MDR Report Key11415050
MDR Text Key239559949
Report Number1036844-2021-00037
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2022
Device Model NumberIPN035619
Device Catalogue NumberCDC-45703-XP1A
Device Lot Number23F20K0033
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/05/2020
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: 03/04/2021 Patient Sequence Number: 1
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