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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. ARROW PRESSURE INJECTABLE CENTRAL VENOUS CATHETERIZATION KIT CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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ARROW INTERNATIONAL, INC. ARROW PRESSURE INJECTABLE CENTRAL VENOUS CATHETERIZATION KIT CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number ASK-45703-PLV
Device Problem Positioning Problem (3009)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/01/2019
Event Type  No Answer Provided  
Event Description
Multi-lumen central venous catheter (cvc) kit malfunction (7 fr. , 3 lumen, 20 cm). During routine guidewire the triple lumen did not pass over the guidewire. Access was lost until a new site could be cannulated. Patient has greater than 70% total body surface area burns, limited access sites, on high drip rates, intermittently requiring vasopressors at the time.
 
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Brand NameARROW PRESSURE INJECTABLE CENTRAL VENOUS CATHETERIZATION KIT
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
ARROW INTERNATIONAL, INC.
312 commerce place
asheboro NC 27203
MDR Report Key8695323
MDR Text Key147875861
Report Number8695323
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberASK-45703-PLV
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/03/2019
Event Location Hospital
Date Report to Manufacturer06/13/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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