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

Model Number	IPN037697
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
The complaint is reported as: the vascular access team was called to remove a single lumen midline.The patient, who was a very small elderly lady, had pulled the pigtail of her catheter.It snapped, leaving the hub within the statlock and the catheter indwelling.No patient harm was reported.No medical intervention was required.The patient's condition is reported as fine.
Event or Problem Description
The complaint is reported as: the vascular access team was called to remove a single lumen midline.The patient, who was a very small elderly lady, had pulled the pigtail of her catheter.It snapped, leaving the hub within the statlock and the catheter indwelling.No patient harm was reported.No medical intervention was required.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one s-l midline catheter for evaluation.Signs of use were observed on the catheter body.The extension line was clamped midway down the body.Visual inspection of the returned catheter revealed the extension line was separated from the juncture hub.The extension line body appeared stretched and deformed near the separation point.The separated edge of the extension line was rough and jagged.Remains of the extension line molding were observed inside the juncture hub.No evidence of contact with a sharp object was observed.No additional defects or anomalies were observed on the catheter body.The catheter body length from the juncture hub to the distal end measured 6 5/8", which is within the specifications of 6 1/4"-6 3/4" per product drawing.The extension line length from the luer hub to the separated end measured 2.5", which is not within the specifications of 1.924"-1.986" per product drawing.This indicates the extension line was stretched during use.The distal extension line outer diameter measured 0.077", which is not within the specifications of 0.093"-0.097" per product drawing.This is consistent with stretching of the extension line caused by undue force.The distal extension line inner diameter at a non-deformed area measured 0.057", which is within the specifications of 0.055"-0.059" per product drawing.The inner diameter of the opening of the juncture hub measured 0.097", indicating the extension line was molded to the correct diameter during manufacturing.Functional inspection of the separated extension line was performed per the instructions for use (ifu) provided with the kit, which states "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the distal extension line was flushed using a lab inventory 10ml syringe.Water was observed exiting the severed end of the extension line.No leaks or blockages were identified.The sample was sent to the wyomissing r & d facility for further inspection and testing.They identified that the appearance of the damage was consistent with excessive, long-term application of tensile forces to the extension line extrusion.They observed the extension line to be elongated and distorted, indicating repeated pulling of the extension line during use.A device history record review was performed, and no relevant findings were identified.The instructions for use (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." the customer report of an extension line/juncture hub separation was confirmed through complaint investigation of the returned sample.Visual inspection revealed the distal extension line separated from the juncture hub.Remains of the extension line molding were observed inside the juncture hub, and the extension line appeared stretched and deformed.The catheter met all relevant functional requirements, and a device history record review was performed with no relevant findings.The appearance of the damage was consistent with excessive force applied to the extension line.Based on these circumstances and the investigation performed by r & d, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW AM/AT PI MIDLINE 1-L: 4.5FR 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: 16734641
• Report Number: 9680794-2023-00256
• Device Sequence Number: 12478213
• Product Code: PND
• UDI-Device Identifier: 10801902130157
• UDI-Public: 10801902130157
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 03/20/2023

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: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: IPN037697
• Device Catalogue Number: CDC-41541-MPK1A
• Device Lot Number: 13F22K0456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2023
• Supplement Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2022
• 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: Female