MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC G4 STYLET: 2L 5.5FR X 55CM BP; CATHETER INTRAVASCULAR THERAPE

Catalog Number	DLX-45552-VPSB
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	06/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "on (b)(6) 2025, patient (b)(6), a 40-year-old female, presented to the clinic for scheduled device removal.Subsequently, the patient developed a catheter-related bloodstream infection (crbsi), which was assessed as severe in intensity.Due to the presence of bacteremia, the patient required hospital readmission.The peripherally inserted central catheter (picc) line was removed on the same day following positive blood culture results.The clinical and microbiological findings confirmed the diagnosis of crbsi." additional information received from the customer states "patient was septic but it is unclear if the etiology is due to the crbsi or worsening osteomyelitis.Patient had also missed a weeks' worth of antibiotics prior to being re-admitted so this could also have been a contributing factor." after the removal of the picc line, patient remained on iv and oral antibiotics and was hospitalized for an additional 6 day, though not in the icu.The patient's current condition is reported as "still struggling with osteomyelitis, she is in stable condition.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.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.
Event or Problem Description
It was reported that "on (b)(6) 2025, patient (b)(6), a 40-year-old female, presented to the clinic for scheduled device removal.Subsequently, the patient developed a catheter-related bloodstream infection (crbsi), which was assessed as severe in intensity.Due to the presence of bacteremia, the patient required hospital readmission.The peripherally inserted central catheter (picc) line was removed on the same day following positive blood culture results.The clinical and microbiological findings confirmed the diagnosis of crbsi." additional information received from the customer states "patient was septic but it is unclear if the etiology is due to the crbsi or worsening osteomyelitis.Patient had also missed a weeks' worth of antibiotics prior to being re-admitted so this could also have been a contributing factor." after the removal of the picc line, patient remained on iv and oral antibiotics and was hospitalized for an additional 6 day, though not in the icu.The patient's current condition is reported as "still strugling with osteomyelits, she is in stable condition.".

• Brand Name: ARROW AGBA PICC G4 STYLET: 2L 5.5FR X 55CM BP
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 23595070
• Report Number: 9680794-2025-00971
• Device Sequence Number: 15779095
• Product Code: LJS
• UDI-Device Identifier: 10801902208627
• UDI-Public: (01)10801902208627(11)250223(17)260227(10)33F25A0320(21)
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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): 06/05/2025

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?: No
• Device Expiration Date: 02/27/2026
• Device Catalogue Number: DLX-45552-VPSB
• Device Lot Number: 33F25A0320
• 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: 06/05/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2025
• 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 Age: 40 YR
• Patient Sex: Female