MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB+; CATHETER INTRAVASCULAR THERAP

Catalog Number	CA-45703-P1A
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Anaphylactic Shock (1703)
Date of Event	07/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the patient experienced an anaphylaxis response to the chlorhexidine in the catheter.The catheter was removed, case was canceled, and patient moved to the icu.The patient had a full recovery within 24 hours.Post removal of catheter, the patient tested positive/sensitive to chg.The patient's current condition was reported as "fine".No information was available regarding the symptoms the patient experienced or the treatment received.
Event or Problem Description
It was reported the patient experienced an anaphylaxis response to the chlorhexidine in the catheter.The catheter was removed, case was canceled, and patient moved to the icu.The patient had a full recovery within 24 hours.Post removal of catheter, the patient tested positive/sensitive to chg.The patient's current condition was reported as "fine".No information was available regarding the symptoms the patient experienced or the treatment received.
Additional Manufacturer Narrative
(b)(4).The device was not returned for investigation.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.The report of a catheter related allergic reaction was confirmed based on the customer report.The customer confirmed that the patient had an allergy/sensitivity to chlorhexidine.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 and customer confirmation of the patient having an 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 PI CVC KIT: 3-L 7 FR X 20 CM AGB+
• Common Device Name: CATHETER INTRAVASCULAR THERAP
• 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: 17388444
• Report Number: 9680794-2023-00560
• Device Sequence Number: 20315626
• Product Code: FOZ
• UDI-Device Identifier: 00801902069528
• UDI-Public: 00801902069528
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2023

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 Catalogue Number: CA-45703-P1A
• Device Lot Number: UNKNOWN
• 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: 07/19/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 09/01/2023
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Sex: Unknown