MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM; CATHETER INTRAVSCULAR THERAPEU

Model Number	IPN037301
Medical Device Problem Codes	Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Hypersensitivity/Allergic reaction (1907); Nausea (1970); Convulsion/Seizure (4406)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the nurse used the chg picc and upon insertion the patient started having symptoms consistent with chg allergy.Patient started feeling nauseous, having heart rate changes, and seizure like movements.A code was called.The nurse removed the catheter right away and the symptoms started to go away.The patient was transferred to icu for 2 days of observation.In (b)(6) 2022, the patient saw an allergist and was confirmed to have an chg allergy.
Event or Problem Description
It was reported the nurse used the chg picc and upon insertion the patient started having symptoms consistent with chg allergy.Patient started feeling nauseous, having heart rate changes, and seizure like movements.A code was called.The nurse removed the catheter right away and the symptoms started to go away.The patient was transferred to icu for 2 days of observation.In (b)(6) 2022, the patient saw an allergist and was confirmed to have an chg allergy.Additional information received 26-may-2023 indicates the patient had no known chg allergy prior to this event.It was also reported that the picc was only in the patient less than 1 minute.The catheter was immediately removed and the patient was treated "per their allergic reaction algorithm (benadryl , levophed, epi, and oxygen)".There were no health consequences from this event.
Additional Manufacturer Narrative
Qn# (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 two findings were identified.It was determined that these findings were not relevant to the failure involved with this complaint.The product label provided with the kit informs the user, "the arrowg+ard blue advance antimicrobial/antithrombogenic catheter is contraindicated for patients with known hypersensitivity to chlorhexidine." the report of a catheter related allergic reaction was confirmed based on the customer report.The customer report confirms that the patient had an allergy to chlorhexidine.The labeling provided with these coated picc catheters states the arrowg+ard blue advance antimicrobial/antithrombogenic catheter is contraindicated for patients with known hypersensitivity to chlorhexidine.The labeling also instructs users to "perform sensitivity testing to confirm allergy to catheter antimicrobial agents if adverse reaction occurs." based on the customer report and that the patient had a confirmed allergy, unintentional use error (patient condition) likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW AGBA PICC/DELTA FG: 2-L 5.5 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: 16976283
• Report Number: 9680794-2023-00349
• Device Sequence Number: 2453205
• Product Code: LJS
• UDI-Device Identifier: 30801902120794
• UDI-Public: 30801902120794
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2023

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: 05/31/2023
• Device Model Number: IPN037301
• Device Catalogue Number: CDC-45552-VPS2
• Device Lot Number: 13F21K0295
• 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: 04/25/2023
• Supplement Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 05/22/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2021
• 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; Hospitalization
• Patient Sex: Unknown