MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PI MIDLINE 1-L: 4.5FR X 15CM; MIDLINE CATHETER

Catalog Number	CDC-41541-MPKC
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "insertion 9/25/24 13:05 rt brachial vein.Sterile chg dressing rapid response team called immediately, patient admitted to icu." the patient's current condition is reported as "critical".Additional information reports "initial call was for for seizures.On arrival the patient was unresponsive, breathing agonally, with a pulse.At that time we called a mayday to have someone assist with intubation and to have a physician to the bedside.We started rescue breathing with a trumpet and then an oral airway until she was successfully intubated.During that time we started a bolus of ns, a levophed drip for bp support for a blood pressure, and then a propofol drip started after she was intubated.At that time we transferred to the icu where the critical care team was prepared and ready.".
Event or Problem Description
It was reported "insertion (b)(6) 2024 13:05 rt brachial vein.Sterile chg dressing rapid response team called immediately, patient admitted to icu." the patient's current condition is reported as "critical".Additional information reports "initial call was for seizures.On arrival the patient was unresponsive, breathing agonally, with a pulse.At that time we called a mayday to have someone assist with intubation and to have a physician to the bedside.We started rescue breathing with a trumpet and then an oral airway until she was successfully intubated.During that time we started a bolus of ns, a levophed drip for bp support for a blood pressure, and then a propofol drip started after she was intubated.At that time we transferred to the icu where the critical care team was prepared and ready.".
Additional Manufacturer Narrative
(b)(4) medwatch received 12-nov-2024, mw5160944.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.Although there was not a clear indication from the customer as to whether or not the patient experienced an allergic reaction, the following information is provided in the instructions for use (ifu) and warns the user, "contraindications: the arrowg+ard blue advance pressure injectable midline is contraindicated for patients with known hypersensitivity to chlorhexidine.Hypersensitivity potential: benefits of the use of this catheter should be weighed against any possible risk.Hypersensitivity reactions are a concern with antimicrobial catheters and can be serious and even life-threatening.Remove catheter immediately if catheter-related adverse reactions occur after catheter placement.".Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW AGBA PI MIDLINE 1-L: 4.5FR X 15CM
• Common Device Name: MIDLINE CATHETER
• 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: 20522673
• Report Number: 9680794-2024-01046
• Device Sequence Number: 18162227
• Product Code: PND
• UDI-Device Identifier: 10801902205435
• UDI-Public: (01)10801902205435(11)240514(17)251130(10)33F24C0525(21)
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K161313
• 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): 09/27/2024

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: 11/30/2025
• Device Catalogue Number: CDC-41541-MPKC
• Device Lot Number: 33F24C0525
• 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: 09/27/2024
• Supplement Date Received by Manufacturer: 11/15/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 11/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2024
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown