MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 6" (16 CM); CATHETER,INTRAVASCULAR,THERAPE

Catalog Number ASK-42703-PBW3

Device Problem Fluid/Blood Leak (1250)

Patient Problems Swelling (2091); Thrombus (2101)

Event Date 02/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

According to the medwatch ((b)(4)) "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.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".

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

According to the medwatch (b)(4) "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.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 CVC SET: 3-LUMEN 7 FR X 6" (16 CM)
• Type of Device: CATHETER,INTRAVASCULAR,THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9953383
• MDR Text Key: 187867001
• Report Number: 9680794-2020-00177
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K993691
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: ASK-42703-PBW3
• Device Lot Number: 14F18J0084
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other