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
Qn#: (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.No patient injury or harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one unopened representative kit from the reported lot.The actual complaint sample was not returned for evaluation.The kit was opened, and the catheter was visually inspected.No defects or anomalies were detected.Visual inspection of the actual sample could not be performed as it was not returned for evaluation.The total length of the representative catheter body measured to be 6.9" which is within specifications of 6.6875-6.9375" per product drawing.The returned representative sample was functionally tested in accordance with the instructions-for-use (ifu) provided with this kit.The ifu instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the representative catheter was flushed using a water-filled lab inventory syringe with minimal resistance.The representative catheter was able to advance over the representative guide wire with minimal resistance.A device history record review was performed with no relevant findings.The ifu provided with this kit instructs the user, "flush each lumen with sterile normal saline for injection to ebstablish patency and prime lumen(s)." the customer report of a blocked catheter could not be confirmed by complaint investigation.The returned representative catheter passed all relevant visual, dimensional, and functional tests.A device history record review was performed with no relevant findings.The probable root cause could not be determined based on the information provided and without the actual complaint sample to evaluate.Teleflex will continue to monitor and trend 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.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: 11766060
• Report Number: 9680794-2021-00190
• Device Sequence Number: 3142202
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• 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