MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW 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
Event or Problem Description
It was reported that: the introducer started peeling back at the edge of the outside piece , making it difficult to insert the whole device into the vessel.Additional information: when the clinician attempted to peel away the sheath one of the white tabs broke off.They were able to pull it back a bit and carefully peel 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).
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 body damaged was able to be confirmed by the photo.The distal tip of the sheath appeared damaged/deformed.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.Investigation from the non-conformance stated that the failure mode cannot be identified as related to procedures not being followed, only awareness meeting was held with personnel for the nonconformance.Escalated investigation was initiated and found no increase in risk level from previous estimates for sample population.Investigation is ongoing to further investigate potential root causes at the manufacturing site.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." teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: the introducer started peeling back at the edge of the outside piece, making it difficult to insert the whole device into the vessel.Additional information: when the clinician attempted to peel away the sheath one of the white tabs broke off.They were able to pull it back a bit and carefully peel 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: ARROW 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: 18968444
• Report Number: 9680794-2024-00259
• Device Sequence Number: 12421835
• 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