MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AM/AT PI MIDLINE 2-L: 5.5FR X 15CM; MIDLINE CATHETER

Model Number	IPN037698
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the midline catheter was placed by the user facility on (b)(6) 2022.The patient was discharged to a skilled nursing facility and returned to the hospital on (b)(6) 2022 because the white hub had fallen off in the skilled nursing facility.No patient harm was reported.The patient's condition was reported to be fine.
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported the midline catheter was placed by the user facility on (b)(6) 2022.The patient was discharged to a skilled nursing facility and returned to the hospital on (b)(6) 2022 because the white hub had fallen off in the skilled nursing facility.No patient harm was reported.The patient's condition was reported to be fine.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one photo for analysis.The photo confirmed the proximal lumen was separated from the extension line.The customer also returned one 2-l cvc catheter for analysis.Signs of use in the form of biological material were observed in the extension lines.Visual inspection confirmed the proximal extension line was completely separated from the luer hub.The proximal luer hub was not returned.The total length of the catheter body measured 6.6875", which is within specifications of 6.625-6.875" per catheter product drawing.The outer diameter of the proximal lumen measured 0.09425", which is within specifications of 0.093-0.097" per product drawing.The inner diameter of the proximal lumen measured 0.056", which is within specifications of 0.055-0.059" per product drawing.This indicates that the wall thickness measured within specifications.The catheter was functionally tested per the instructions for use (ifu).The ifu provided with this kit states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." when the distal line was flushed no leaks or blocks were detected.A manual tug test confirmed the distal extension line was secure to its luer hub.A device history record review was performed with no relevant findings.The ifu provided with this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause catheter component damage or breakage.If placement damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested.Do not secure, staple, and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the report of an extension line/luer hub separation was confirmed by a complaint investigation.Visual analysis revealed that the proximal extension line was separated from the luer hub.The proximal luer hub was not returned for analysis.Without the luer hub returned, the root cause could not be determined.Teleflex will continue to monitor and trend complaints of this nature.

• Brand Name: ARROW AM/AT PI MIDLINE 2-L: 5.5FR X 15CM
• Common Device Name: MIDLINE CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 15224771
• Report Number: 9680794-2022-00491
• Device Sequence Number: 5977556
• Product Code: PND
• UDI-Device Identifier: 50801902130162
• UDI-Public: 50801902130162
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2022

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
• Device Expiration Date: 08/31/2023
• Device Model Number: IPN037698
• Device Catalogue Number: CDC-41552-MPK1A
• Device Lot Number: 13F22B0608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown