MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AGBA PICC/DELTA KIT: 1-L 4.5 FR X 50 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CDC-45041-VPS2
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Anaphylactic Shock (1703); Cardiac Arrest (1762); Hypersensitivity/Allergic reaction (1907); Rash (2033); Vomiting (2144)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: the patient had an anaphylactic reaction.They were resuscitated in the icu.Additional information: clinician states he was critical, but is now fine.Patient was extubated (b)(6) 2023.
Additional Manufacturer Narrative
Qn#(b)(4).Although no sample was available for investigation, the complaint can be confirmed based on the additional information provided by the customer.The patient experienced anaphylactic shock which resulted in full cardiac arrest as well as cpr and intubation.A device history record review was performed, and no relevant findings were identified to suggest a manufacturing related issue.The instructions for use (ifu) provided with this kit warns the user, "the pressure injectable arrowg+ard blue advance antimicrobial/antithrombogenic 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 complaint of catheter related allergic reaction is confirmed based on the information provided by the customer.The customer reported that a severe patient reaction occurred during the placement of an antimicrobial coated picc catheter.The customer also stated that an antimicrobial coated cvc was inserted after the reported reaction, with no observed side effects in the patient.Regardless, the customer stated that allergy testing was performed on the patient and it confirmed an allergy to chlorhexidine.No sample was returned for investigation.A device history record review was performed, and no relevant findings were identified to suggest a manufacturing related issue.Based on the available information, the complaint is confirmed and the root cause is attributed to unintentional use error (patient condition) due to the patient allergy to chlorhexidine.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: the patient had an anaphylactic reaction.They were resuscitated in the icu.Additional information: clinician states he was critical, but is now fine.Patient was extubated (b)(6) 2023.

• Brand Name: AGBA PICC/DELTA KIT: 1-L 4.5 FR X 50 CM
• 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: 18788501
• Report Number: 9680794-2024-00124
• Device Sequence Number: 7757118
• Product Code: LJS
• UDI-Device Identifier: 60801902120740
• UDI-Public: 60801902120740
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 02/02/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/12/2024
• Device Catalogue Number: CDC-45041-VPS2
• Device Lot Number: 33F23C0762
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male