MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC NAVICURVE: 1L 4.5FR X 55CM TCG; CATHETER, INTRAVASCULAR, THERA

Catalog Number	DLX-45541-CURVC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported "we had a patient they feel went into anaphylaxis while the picc was inserted the other day".Additional information from the hospital indicated that the patient experienced diaphoresis, itching, difficulty breathing and seizure like movements.The patient was treated with epinephrine and steroids and was under monitoring.The condition of the patient is reported as 'stable' and the patient returned to the previous hemodynamics.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one one-lumen picc catheter for investigation.Visual examination of the catheter did not reveal any defects or anomalies.The catheter coating appeared typical with no discoloration.The returned sample was functionally tested in accordance with the instructions for use (ifu) provided with this kit.The ifu instructs, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)".The returned catheter was flushed using a lab inventory syringe to ensure no blockages were present.The catheter flushed as expected.No anomalies were detected.Additional testing of the catheter coating could not be performed as the catheter was inserted into the patient.Once the catheter is inserted, the coating begins to release within the bloodstream.A device history record review was performed with no relevant findings.The ifu provided with this kit warns the user, "the arrowg+ard blue antimicrobial catheter is contraindicated for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine and/or sulfa drugs.Remove catheter immediately if adverse reactions occur after catheter placement.Note: perform sensitivity testing to confirm allergy to catheter antimicrobial agents, if adverse reaction occurs." the customer report of an allergic reaction could not be confirmed based on the customer information provided or complaint investigation of the returned catheter.The catheter passed all relevant testing.A device history record review was performed with no relevant findings.The customer did not confirm whether the patient was tested for allergy sensitivity prior to or after catheter insertion.Therefore, the complaint cannot be confirmed and the probable root cause could not be determined.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported "we had a patient they feel went into anaphylaxis while the picc was inserted the other day".Additional information from the hospital indicated that the patient experienced diaphoresis, itching, difficulty breathing and seizure like movements.The patient was treated with epinephrine and steroids and was under monitoring.The condition of the patient is reported as 'stable' and the patient returned to the previous hemodynamics.

• Brand Name: ARROW AGBA PICC NAVICURVE: 1L 4.5FR X 55CM TCG
• 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: 21274154
• Report Number: 9680794-2025-00094
• Device Sequence Number: 8071406
• Product Code: LJS
• UDI-Device Identifier: 10801902208726
• UDI-Public: (01)10801902208726(11)240927(17)260227(10)33F24D0755(21)
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K220363
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2026
• Device Catalogue Number: DLX-45541-CURVC
• Device Lot Number: 33F24D0755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 02/18/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• 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