MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AGBA PI MIDLINE 2-L: 5.5FR X 15CM; MIDLINE CATHETER

Catalog Number	CDC-41552-MPKB
Medical Device Problem Codes	Material Deformation (2976); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that the "sheath broke during insertion and they had to open a standalone".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one peel-away sheath for evaluation.Signs of use were observed.Visual inspection of the peel-away sheath revealed that the sheath had split completely down the length of the extrusion.One of the tabs did not tear correctly resulting in the extrusion to separate, but with a portion of the extrusion remaining attached to the tab.The separation points of the extrusion as well as the tear lines on the extrusion appeared stretched.The sheath extrusion from the tab to the distal tip measured 2 13/16", which is within the specification limits of 2 5/8"-2 7/8" per the peel-away product drawing.The sheath outer diameter/inner diameter could not be accurately measured.Functional inspection could not be accurately performed due to the condition of the returned sample.A device history record review was performed, and there was one potential finding.A non-conformance was initiated for lot 34c23k0189 in regard to "peel-away sheath tears incorrectly".The failure mode of this complaint is the same as/relevant to the non-conformance identified.The report that a peel-away did not tear correctly was confirmed through complaint investigation.Visual analysis revealed that the sheath split completely along the length of the extrusion; however, one side of the extrusion had separated with a portion of the extrusion remaining attached to the tab.Based on the customer report, 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.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that the "sheath broke during insertion and they had to open a standalone".No patient harm or injury.The patient status is reported as "fine".

• Brand Name: AGBA PI MIDLINE 2-L: 5.5FR 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: 19391004
• Report Number: 9680794-2024-00555
• Device Sequence Number: 15192309
• Product Code: PND
• UDI-Device Identifier: 10801902205428
• UDI-Public: 10801902205428
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2024

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 Expiration Date: 05/31/2025
• Device Catalogue Number: CDC-41552-MPKB
• Device Lot Number: 33F23K0405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• 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: N/A.; N/A.
• Patient Sex: Unknown