MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AM/AT PI MIDLINE 1-L: 4.5FR X 15CM; MIDLINE CATHETER

Model Number IPN037697

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#:(b)(4).

Event Description

Customer reported the catheter would not provide blood return immediately after placement.The line was pulled back and still no blood return.It was reported the midline was placed in a large, right basilic vessel.No difficulty during insertion.The line flushed easily and was primed before insertion with no leaking noted.A new kit was opened and the user did an over-wire catheter exchange, and like before there was no blood return once inserted, despite receiving blood return when dilating.No patient injury or harm reported.The patient's condition is reported as fine.

Event Description

Customer reported the catheter would not provide blood return immediately after placement.The line was pulled back and still no blood return.It was reported the midline was placed in a large, right basilic vessel.No difficulty during insertion.The line flushed easily and was primed before insertion with no leaking noted.A new kit was opened and the user did an over-wire catheter exchange, and like before there was no blood return once inserted, despite receiving blood return when dilating.No patient injury or harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn#(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.

• Brand Name: ARROW AM/AT PI MIDLINE 1-L: 4.5FR X 15CM
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11766226
• MDR Text Key: 249293989
• Report Number: 9680794-2021-00192
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 50801902130155
• UDI-Public: 50801902130155
• Combination Product (y/n): N
• PMA/PMN Number: K161313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/31/2022
• Device Model Number: IPN037697
• Device Catalogue Number: CDC-41541-MPK1A
• Device Lot Number: 13F20J0848
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1