MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI AGBA PICC KIT: 2L 5.5 FR X 55 CM VPS; CATHETER, INTRAVASCULAR, THERA

Catalog Number	ASK-45552-UOI1
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "we had a picc that cracked above the insertion site and they found a "lump" on the patient's skin while doing the dressing change.They were changing the dressing because it was profusely bleeding".Additional information received states the profuse bleeding did not originate from the crack in the catheter.However, a hematoma was present.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported that "we had a picc that cracked above the insertion site and they found a "lump" on the patient's skin while doing the dressing change.They were changing the dressing because it was profusely bleeding".Additional information received states the profuse bleeding did not originate from the crack in the catheter.However, a hematoma was present.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of a picc with a hole was able to be confirmed by the photo.The catheter body appears to have a hole, from which blood leaked.Definite signs of use were observed.The appearance of the hole is consistent with a pressure-related rupture; however, a complete visual inspection to determine the cause of the damage could not be performed as no sample was returned for analysis.A device history record review was performed , and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "use only lumen (s) labeled "pressure injectable" for pressure injection to reduce risk of catheter failure and/or patient complications.Refer to the arrow pressure injection information label for pressure injection information." without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date , a follow-up report will be submitted with investigation results.

• Brand Name: ARROW PI AGBA PICC KIT: 2L 5.5 FR X 55 CM VPS
• Common Device Name: CATHETER, INTRAVASCULAR, THERA
• 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: 24080037
• Report Number: 9680794-2026-00074
• Device Sequence Number: 5878984
• Product Code: LJS
• UDI-Device Identifier: 10801902221671
• UDI-Public: (01)10801902221671(11)250212(17)260619(10)33F25A0082(21)
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K112896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2025

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: 06/19/2026
• Device Catalogue Number: ASK-45552-UOI1
• Device Lot Number: 33F25A0082
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 01/15/2026
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2025
• 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