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

Catalog Number	CDC-45541-VPS2
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	08/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported "patient had an agba picc inserted and within seconds had an anaphylactic reaction.Patient's throat closed causing an emergency.The picc catheter was removed immediately." the patient required anaphylaxis medications in line with acls regimen.A new vascular access was placed.The patient's current condition is reported as fine.
Event or Problem Description
It was reported "patient had an agba picc inserted and within seconds had an anaphylactic reaction.Patient's throat closed causing an emergency.The picc catheter was removed immediately." the patient required anaphylaxis medications in line with acls regimen.A new vascular access was placed.The patient's current condition is reported as fine.
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.The instructions for use (ifu) provided with this kit warns the user, "contraindications: the pressure injectable arrowg+ard blue advance antimicrobial/antithrombogenic catheter is contraindicated: for patients with known hypersensitivity to chlorhexidine." the complaint of catheter related allergic reaction could not be confirmed.No sample was returned for investigation.The customer reported that allergy testing was going to be performed to confirm a chlorhexidine allergy, however the results of the allergy test were not received for the investigation.A device history record review was performed, and no relevant findings were identified to suggest a manufacturing related issue.Therefore, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.Corrected data: section d.1.Brand name corrected to arrow agba picc/delta kit: 1-l 4.5 fr x 55 cm.Section d.4.-catalog# corrected to cdc-45541-vps2.Section d.4.-udi# corrected to (b)(4).

• Brand Name: ARROW AGBA PICC/DELTA KIT: 1-L 4.5 FR X 55 CM
• Common Device Name: CATHETER INTRAVSCULAR THERAPEU
• 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: 17718758
• Report Number: 9680794-2023-00675
• Device Sequence Number: 7163598
• Product Code: LJS
• UDI-Device Identifier: 50801902120781
• UDI-Public: 50801902120781
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2023

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
• Device Expiration Date: 08/03/2024
• Device Catalogue Number: CDC-45541-VPS2
• Device Lot Number: 33F23C0724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 10/10/2023
• 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: Life Threatening; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 108 KG