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

Catalog Number	CDC-41541-MPKC
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer returned one peel away sheath for analysis.No definite signs of use were observed.Visual inspection revealed that the peel-away sheath extrusion was torn directly adjacent to one tab.The separated tab was not returned for analysis.The tab was additionally observed to be separated.Microscopic examination confirmed the damage and revealed that the sheath was torn completely down one score line.The total length of the sheath measured 2 3/4", which is within the specification limits of 2 5/8 - 2 7/8" per the sheath product drawing.The sheath outer and inner diameters could not be accurately measured due to the nature of the damage.Functional testing could not be performed as a part of this complaint investigation due to the condition of the returned sample.A device history record review was performed, and relevant findings were identified.A non-conformance was identified for part number eb-01042-002 with batch 34c24c0307 regarding a "peel-away sheath tears incorrectly" defect.Further review of the finding revealed that it was not relevant to the reported event.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 of a broken peel away sheath tab was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the sheath extrusion had separated directly adjacent to one tab.The tab was additionally partially separated.Based on the customer report and the sample received, manufacturing likely 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 "when it came time to break-away/remove the glide-thru peel-away sheath, a portion of the white sheath body broke away from the break-away tab/handle prematurely, not allowing the sheath removal process to be completed.The midline & sheath were fully removed as a unit, a new kit was opened, & the procedure was completed successfully." 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 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20797366
• Report Number: 9680794-2024-01171
• Device Sequence Number: 12714877
• Product Code: PND
• UDI-Device Identifier: 10801902205435
• UDI-Public: (01)10801902205435(11)240529(17)251231(10)33F24D0483(21)
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2024

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: 12/31/2025
• Device Catalogue Number: CDC-41541-MPKC
• Device Lot Number: 33F24D0483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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: NOT REPORTED
• Patient Sex: Unknown