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

Catalog Number	PR-41552-BAS
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It is reported that: "an attempt is made to insert a 5.5 fr bilumen medical line catheter, but despite cutting the skin with a scalpel that comes in the kit and performing a screw technique when inserting a dilator + peelable, the device malfunctions because the peelable was broken , so a catheter change is requested to complete insertion of venous access." there was no reported patient harm or consequence.
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided three photos for evaluation.The complaint of peel-away sheath body damaged was able to be confirmed by the photos.The distal tip of the sheath appeared damaged/deformed.It appears the tip is partially split along.The score lines.A device history record review was performed, and there was one potential finding.A non-conformance initiated for lot#: 34c24a0272 in regard to "peel-away sheath tears incorrectly".The failure mode of this complaint may be the same as/relevant to the non-conformance identified.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." the customer report of peel-away sheath body damaged was confirmed by visual inspection of the customer supplied photos.The images show a peel-away sheath with a distal tip that was damaged/deformed.Without the device to evaluate, the probable cause could not be determined from the available information, however, a non-conformance was initiated to further investigate potential root causes at the manufacturing site.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It is reported that: "an attempt is made to insert a 5.5 fr bilumen medical line catheter, but despite cutting the skin with a scalpel that comes in the kit and performing a screw technique when inserting a dilator + peelable, the device malfunctions because the peelable was broken, so a catheter change is requested to complete insertion of venous access." there was no reported patient harm or consequence.

• Brand Name: ARROW AGBA PI MIDLINE 2L: 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: 20157108
• Report Number: 9680794-2024-00948
• Device Sequence Number: 14512430
• Product Code: PND
• UDI-Device Identifier: 10801902136586
• UDI-Public: (01)10801902136586(11)240204(17)250404(10)33F23M0219(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K161313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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: 04/04/2025
• Device Catalogue Number: PR-41552-BAS
• Device Lot Number: 33F23M0219
• 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: 07/09/2024
• Supplement Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2024
• 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: Female