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

Model Number	IPN037697
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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.
Additional 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 or Problem 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.

• Brand Name: ARROW AM/AT PI MIDLINE 1-L: 4.5FR X 15CM
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11766217
• Report Number: 9680794-2021-00191
• Device Sequence Number: 3142203
• Product Code: PND
• UDI-Device Identifier: 50801902130155
• UDI-Public: 50801902130155
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2021

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1