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

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.

• Brand Name: ARROW
• Type of Device: CATHETER,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 Key: 9824120
• MDR Text Key: 183155955
• Report Number: 9824120
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN032810
• Device Catalogue Number: ASK-42703-PBW3
• Device Lot Number: 14F18J0084
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other