MAUDE Adverse Event Report: ARROW CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER,INTRAVASCULAR,THERAP

Model Number IPN030921

Device Problem Infusion or Flow Problem (2964)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 06/11/2021

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).

Event Description

Customer reported that "patient has had this central line in for 3 days.Blood products were ran through the transducer line by day staff.Once finished, i flushed the transducer line and this subsequently caused patient's systolic to rise to 250.I then stopped the norad (12/50) and slowly reintroduced.Due to concern that the transducer somehow flushed the norad even though they are on separate lumens, i transferred the norad to another lumen.I then flushed another lumen on the central line and this happened again.In total flushing the central line caused patient's systolic to rise to unsafe ranges 3 times." the cvc line was changed.No other medical intervention was reported.The patient's condition was unknown.

Manufacturer Narrative

(b)(4).The actual sample was not returned; however, the customer supplied one photo of a 4-lumen cvc for evaluation.The medial (gray luer) lumen contained a white substance.However, the customer report could not be confirmed based on the supplied photo.A full visual inspection of the catheter could not be performed as no sample was returned for analysis.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The instructions-for-use provided with this kit warns the user, "using catheters not indicated for high pressure injection for such applications can result in inter-lumen crossover or rupture with potential for injury." complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on a potential lot identified from sales history 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

Customer reported that "patient has had this central line in for 3 days.Blood products were ran through the transducer line by day staff.Once finished, i flushed the transducer line and this subsequently caused patient's systolic to rise to 250.I then stopped the norad (12/50) and slowly reintroduced.Due to concern that the transducer somehow flushed the norad even though they are on separate lumens, i transferred the norad to another lumen.I then flushed another lumen on the central line and this happened again.In total flushing the central line caused patient's systolic to rise to unsafe ranges 3 times." the cvc line was changed.No other medical intervention was reported.The patient's condition was unknown.

Manufacturer Narrative

Qn# (b)(4).The customer returned one 4-lumen cvc for evaluation.All four luer hubs contained caps and a box clamp was returned on the catheter body.No defects or anomalies were detected.The total length of the catheter body measured to be 172 mm which is within specifications of 157-177 mm per product drawing.The instructions-for-use (ifu) provided with this kit states, "flush lumen(s) to completely clear blood from catheter." all four lumens were flushed using a water-filled lab inventory syringe.No leaks or blockages were detected.When each lumen was flushed, water exited the respective skive location.No issues were detected.The returned catheter body was clamped at the distal end.Each lumen was again flushed to ensure no backflow was present.No issues were identified.A lab inventory guide wire was advanced through the distal lumen and exited through the distal tip.No issues were identified.The ifu provided with this kit warns the user, "using catheters not indicated for high pressure injection for such applications can result in inter-lumen crossover or rupture with potential for injury." the customer report of inter lumen crossover could not be confirmed through functional testing of the returned sample.The catheter passed all relevant visual, dimensional, and functional testing, and a device history record review was performed on a potential lot identified from the sales history of the customer and no relevant findings were identified.No problem was found with the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

Customer reported that "patient has had this central line in for 3 days.Blood products were ran through the transducer line by day staff.Once finished, i flushed the transducer line and this subsequently caused patient's systolic to rise to 250.I then stopped the norad (12/50) and slowly reintroduced.Due to concern that the transducer somehow flushed the norad even though they are on separate lumens, i transferred the norad to another lumen.I then flushed another lumen on the central line and this happened again.In total flushing the central line caused patient's systolic to rise to unsafe ranges 3 times." the cvc line was changed.No other medical intervention was reported.The patient's condition was unknown.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 16CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• MDR Report Key: 12122465
• MDR Text Key: 260095391
• Report Number: 3006425876-2021-00591
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10801902029345
• UDI-Public: 10801902029345
• Combination Product (y/n): N
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN030921
• Device Catalogue Number: CV-22854
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Initial Date Manufacturer Received: 06/11/2021
• Initial Date FDA Received: 07/06/2021
• Supplement Dates Manufacturer Received: 07/16/2021; 08/19/2021
• Supplement Dates FDA Received: 07/20/2021; 08/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NORAD; NORAD; NORAD; NORAD
• Patient Outcome(s): Other