MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AM PICC 1L 4.5FRX55CM 130CM HYDR NIT SWG; CATHETER INTRAVASCULAR THERAPE

Catalog Number	PR-45541-HPHNL
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Anaphylactic Shock (1703); Hypersensitivity/Allergic reaction (1907)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that: the patient had an anaphylactic reaction while the picc was being inserted.Epinephrine and steroids were administered, and the patient was reported as fine post the incident.Additional information has been requested from the account.
Additional Manufacturer Narrative
(b)(4) complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Allergy testing was not performed to confirm that chlorhexidine, which is the antimicrobial coating on the catheter, was the cause of the allergic reaction.Therefore, the complaint cannot be confirmed and the root cause of this event cannot be determined based on the available information.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 while the picc was being inserted.Epinephrine and steroids were administered, and the patient was reported as fine post the incident.Additional information has been requested from the account.

• Brand Name: ARROW AM PICC 1L 4.5FRX55CM 130CM HYDR NIT SWG
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18037190
• Report Number: 9680794-2023-00900
• Device Sequence Number: 8268897
• Product Code: LJS
• UDI-Device Identifier: 00801902095749
• UDI-Public: 00801902095749
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2024
• Device Catalogue Number: PR-45541-HPHNL
• Device Lot Number: 13F22G0580
• 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: 10/26/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/12/2022
• 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; NOT REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown