MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 2L 8 FR; CATHETER INTRAVASCULAR THERAPE

Catalog Number	ASK-42802-TGH1
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Codes	Anaphylactic Shock (1703); Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)
Date of Event	06/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn#(b)(4).Associated mdr#s 9680794-2023-00551 and 9680794-2023-00550.
Event or Problem Description
It was reported 30 minutes after the cvc was placed in an 81 year old male, the patient's blood pressure dropped to 50/30 and heart rate dropped.Cvc was removed and patient treated with steroids, epinephrine, and fluids.A second cvc was inserted and the patient experienced the same symptoms.Patient returned to normal signs after treatment.The patient's current condition was reported to be stable and he was released from hospital.
Additional Manufacturer Narrative
(b)(4).Associated mdr#s 9680794-2023-00551 and 9680794-2023-00550.The report of a catheter related allergic reaction was confirmed based on the customer report.The customer report confirmed that the patient experienced anaphylactic shock symptoms due to chlorhexidine exposure.The customer used two different catheters coated in chlorhexidine and the patient experienced the same reaction twice.The labeling provided with the coated catheter states "the arrowg+ard blue antimicrobial catheter is contraindicated for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine and/or sulfa drugs." therefore, based on the reported event, unintentional use error (patient condition) likely caused or contributed to this event.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported 30 minutes after the cvc was placed in an 81 year old male, the patient's blood pressure dropped to 50/30 and heart rate dropped.Cvc was removed and patient treated with steroids, epinephrine, and fluids.A second cvc was inserted and the patient experienced the same symptoms.Patient returned to normal signs after treatment.The patient's current condition was reported to be stable and he was released from hospital.

• Brand Name: ARROW PI CVC KIT: 2L 8 FR
• 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: 17434081
• Report Number: 9680794-2023-00550
• Device Sequence Number: 6834703
• Product Code: FOZ
• UDI-Device Identifier: 10801902213829
• UDI-Public: 10801902213829
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• 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): 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ASK-42802-TGH1
• 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: 07/06/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 08/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 81 YR
• Patient Sex: Male