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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. (SUSIDIARY OF TELEFLEX, INC.) ARROW CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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ARROW INTERNATIONAL, INC. (SUSIDIARY OF TELEFLEX, INC.) ARROW CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number IPN032810
Device Problem Leak/Splash (1354)
Patient Problems Sepsis (2067); Swelling (2091)
Event Date 02/20/2020
Event Type  malfunction  
Event Description
The pt needed more stable access in the setting of sepsis, so nurse placed a non-tunneled iv in the right internal jugular (rij) vein. The following day, iv rn noted rij was leaking and per her note, paged overnight md. Pt's triple lumen iv was noted to be leaking when it was flushed with normal saline. The absorbable hemostat was soaked immediately while the proximal port was being flushed. The following morning, respiratory care was notified of concern for leaking. On exam, patient's arm was severely swollen to twice the size of her left arm. Iv fluids were stopped, rij was removed by iv team, and with permission from nephrology, a midline was placed by iv team. To ensure not missing a blood clot, a rue duplex was ordered, which showed a rij blood clot. Swelling is likely from a combination of ivf leaking into her arm all night plus the clot.
 
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Brand NameARROW
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
ARROW INTERNATIONAL, INC. (SUSIDIARY OF TELEFLEX, INC.)
2400 bernville road
reading PA 19605
MDR Report Key9824120
MDR Text Key183155955
Report Number9824120
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 Other Health Care Professional
Type of Report Initial
Report Date 03/02/2020,02/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPN032810
Device Catalogue NumberASK-42703-PBW3
Device Lot Number14F18J0084
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/02/2020
Event Location Hospital
Date Report to Manufacturer03/12/2020
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? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/12/2020 Patient Sequence Number: 1
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