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

Catalog Number	CDC-41541-MPK1A
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Codes	Pain (1994); Skin Tears (2516)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "broke apart while in the patient and was very difficult to remove, as one of the wings on the white breakaway sides separated from the rest of it." additional information: when the clinician attempted to peal away the sheath one of the white tabs broke off.They were able to pull it back a bit and carefully peal away the introducer from the catheter with the one handle.The procedure was completed successfully and there was no patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided a photo for analysis.The complaint of a peel-away sheath tab breaking off was able to be confirmed by the photo.One of the tabs from the peel-away sheath appeared separated adjacent to the sheath extrusion.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number taken from the sales history data of the customer, and one finding was identified.A non-conformance initiated for lot 34c22h0277 in regard to "peel-away sheath tears incorrectly".Without the sample returned, it cannot be confirmed if the failure mode of this complaint is the same as/relevant to the non-conformance 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.Do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator, or tissue dilator as this can lead to vessel perforation and bleeding, or component damage." the customer report of a peel-away sheath tab breaking off was confirmed by visual inspection of the customer supplied photo.The photo shows the peel-away sheath tab broken adjacent to the sheath extrusion.Past comments from manufacturing confirmed that the type of defect observed is a manufacturing issue.Non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "broke apart while in the patient and was very difficult to remove, as one of the wings on the white breakaway sides separated from the rest of it." additional information: when the clinician attempted to peal away the sheath one of the white tabs broke off.They were able to pull it back a bit and carefully peal away the introducer from the catheter with the one handle.The procedure was completed successfully and there was no patient harm or consequence.

• Brand Name: AM/AT PI MIDLINE 1L: 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18968382
• Report Number: 9680794-2024-00258
• Device Sequence Number: 20407962
• Product Code: PND
• UDI-Device Identifier: 50801902130155
• UDI-Public: 50801902130155
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 02/27/2024

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 Catalogue Number: CDC-41541-MPK1A
• Device Lot Number: 33F23H106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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