MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 55 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN037306
Medical Device Problem Codes	Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Nausea (1970); Loss of consciousness (2418); Convulsion/Seizure (4406)
Date of Event	02/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
Medwatch form received reports: "picc line insertion.Case proceeded normally until line was in superior vena cava.While positioning the last few cm, patient stated he was feeling nauseous.Patient felt the need to urinate.Patient then began having seizure like movements.Patient became unresponsive.Procedure aborted.Code blue called.Discovered to be an allergic reaction to the chlorehexidine.".
Event or Problem Description
Medwatch form received reports: "picc line insertion.Case proceeded normally until line was in superior vena cava.While positioning the last few cm, patient stated he was feeling nauseous.Patient felt the need to urinate.Patient then began having seizure like movements.Patient became unresponsive.Procedure aborted.Code blue called.Discovered to be an allergic reaction to the chlorehexidine." additional information received from the sales rep 25-apr-2023 indicates the patient has a complex medical history with several allergies.It was also reported that the code blue was called when the patient's heart rate changed, and the patient became unresponsive but never lost pulse.They needed to remove the catheter and treat the patient with levophed, epi, benadryl and oxygen.Shortly after removal of the line and treatment, the allergy-like symptoms resolved.The patient was transferred to the icu for just under 24 hours for observation.There was no injury to the patient and the current condition of the patient was reported as "fine".The patient was to follow up with an allergist to confirm the chg allergy; however, it was reported that the patient cancelled their last allergy test appointment with the clinic and will "follow up at a later date".
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.The customer report of an allergic reaction was not able to be confirmed by the event details of the reported complaint.The pressure injectable arrowg+ard blue advance antimicrobial/antithrombogenic catheter is contraindicated for patients with known hypersensitivity to chlorhexidine, however, it was not confirmed that the patient has a hypersensitivity to chlorhexidine.Based on the information available at this time, the root cause cannot be determined.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 55 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: 16620205
• Report Number: 9680794-2023-00224
• Device Sequence Number: 5923914
• Product Code: LJS
• UDI-Device Identifier: 50801902120781
• UDI-Public: 50801902120781
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2023

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: 11/30/2023
• Device Model Number: IPN037306
• Device Catalogue Number: CDC-45541-VPS2
• Device Lot Number: 13F22L0485
• 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: 03/07/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 05/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2022
• 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; VANCOMYCIN AND OPIOIDS
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Male