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

Catalog Number	PR-41541-BAS
Medical Device Problem Codes	Crack (1135); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer returned one peel-away sheath for analysis.Signs of use in the form of biological material were observed on the sheath extrusion and tabs.Visual inspection revealed that one side of the peel-away sheath tore partway down the extrusion, causing the tab and extrusion to separate from the distal portion of the sheath.Microscopic examination confirmed the damage and revealed that the sheath was torn completely down both score lines.It was additionally noted that the tear at the score lines was partially scalloped, which is not the intended appearance of the score lines once torn.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator, or tissue dilator as this can lead to venospasm, vessel perforation, bleeding, or component damage".The report that a peel-away did not tear correctly was confirmed through complaint investigation of the returned sample.Visual analysis revealed that one side of the extrusion tore partway, causing the tab and extrusion to separate from the distal end of the extrusion.The appearance of the torn score lines was also partially scalloped which is not the sheath's intended appearance.Based on the customer report and the sample received, manufacturing caused or contributed to this event.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "dilator cracked in the middle of sheath while pulling sheath away from catheter." additional information clarifies "the peel away sheath tears incorrectly." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW AGBA 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20382553
• Report Number: 9680794-2024-00975
• Device Sequence Number: 8066092
• Product Code: PND
• UDI-Device Identifier: 10801902136579
• UDI-Public: (01)10801902136579(11)240512(17)260206(10)33F24D0464(21)
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/10/2024

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
• Device Expiration Date: 02/06/2026
• Device Catalogue Number: PR-41541-BAS
• Device Lot Number: 33F24D0464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2024
• 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: NONE REPORTED
• Patient Sex: Male