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

Catalog Number	CDC-41541-MPKB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "the wings are breaking off as the sheath is being removed.There was no reported patient harm or consequence." associated complaint 9680794-2025-00061.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned four unopened midline kits for analysis.The customer reported that the damage was identified during the procedure; therefore, the samples were investigated with the assumption that the returned kits were representative samples.The returned kits were opened to further analyze the sheaths.No obvious defects or anomalies were identified with the sheaths.The overall length of one sheath measured 2 3/4" which is within the specification limits of 2 5/8 - 2 7/8" per the sheath product drawing.The outer diameter of the sheath measured 0.0800" which is within the specification limits of 0.078 - 0.084" per the sheath extrusion drawing.The inner diameter of the sheath measured 0.068" which is within the specification limits of 0.066 - 0.071" per the sheath extrusion drawing.One sheath was functionally tested per the instructions for use (ifu) provided with this kit which instructs the user, "ensure dilator is in position and locked to hub of sheath.".The sheath was removed and then reinserted into the dilator.The dilator hub was then locked into the sheath tabs as intended.Tearing of the sheath was simulated with one of the returned representative sheaths.With the catheter advanced through the sheath, the tabs were separated and then torn down the score lines.The sheath was able to separate and tear as intended.Performed per ifu statement, "withdraw peel-away sheath over catheter until sheath hub and connected portion of sheath is free from venipuncture site.Grasp tabs of peel away sheath and pull away from the catheter, while withdrawing from vessel until sheath splits down its entire length." a device history record review was performed and no relevant findings were identified.The ifu provided with this kit informs the user, "precaution: avoid tearing sheath at insertion site which opens surrounding tissue creating a gap between catheter and dermis." the customer report of a broken peel away sheath tab could not be confirmed through the investigation of the returned samples.The customer reported a defect "in use" but returned four unopened kits for analysis.Therefore, the returned kits were investigated as representative samples.One sheath was analyzed, and it passed all relevant visual, dimensional, and functional requirements.Therefore, based on the representative sample received and since the reported sheath was not returned for analysis, the potential root cause could not be confirmed at this time.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that: "the wings are breaking off as the sheath is being removed.There was no reported patient harm or consequence." associated complaints 9680794-2025-00060 and 9680794-2025-00061.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21136493
• Report Number: 9680794-2025-00060
• Device Sequence Number: 6958024
• Product Code: PND
• UDI-Device Identifier: 10801902205411
• UDI-Public: (01)10801902205411(11)240918(17)251231(10)33F24J0021(21)
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2024

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: 12/31/2025
• Device Catalogue Number: CDC-41541-MPKB
• Device Lot Number: 33F24J0021
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2024
• 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; NOT REPORTED
• Patient Sex: Unknown