MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTI-LUMEN/PSI KIT; INTRODUCER CATHETER

Catalog Number	AK-21242-X
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Anaphylactic Shock (1703)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "within 3 minutes of placement of mac catheter, patient had an anaphylactic shock.As the anaesthesia staff and or team were made aware that the patient had a chlorhexidine allergy this morning, they did not use any subsidiary chlorhexidine products (mouth scubs, sage cloths, etc).However, the patient did use chlorhexidine wipes at home the night before and had hives on his skin when he arrived to pre-op (which is when they became aware of his allergy).Anaesthesia was not aware that the mac catheter was impregnated with chlorhexidine silver-sulfadiazine so it was used.Patient coded before the chest was cracked open and patient was put in a balloon pump.Additional information: anaphylactic shock to asystole cardiac arrest intraop.Patient treated with pepsid, benadryl, and steroid.The patient was stabilized after they opened the chest.Treatment after anaphylactic reaction: acls, cpr, steroids, ivf, intubation, and icu.Patient is extubated, awake, communicative, and on 2l o2 currently.Has returned to baseline with wheezing.".
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 arrowg+ard blue antimicrobial catheter is contraindicated for patients with known hypersensitivity to chlorhexidine acetate, silver sulfadiazine, and/or sulfa drugs.Warning: remove catheter immediately if adverse reactions occur after catheter placement.Chlorhexidine containing compounds have been used as topical disinfectants since the mid-1970's.An effective antimicrobial agent, chlorhexidine found use in many antiseptic skin creams, mouth rinses, cosmetic products, medical devices and disinfectants used to prepare the skin for a surgical procedure." the complaint of catheter related allergic reaction was confirmed based on the customer provided details of the event.Per the customer report, "the anesthesia staff and or team were made aware that the patient had a chlorhexidine allergy.Anesthesia was not aware that the mac catheter was impregnated with chlorhexidine silver-sulfadiazine so it was used." a review of the instructions for use (ifu) provided with this product states, "contraindications: the arrowg+ard blue antimicrobial catheter is contraindicated for patients with known hypersensitivity to chlorhexidine acetate, silver sulfadiazine, and/or sulfa drugs." a dhr review was performed with no relevant findings identified.Therefore, based on the available information provided by the customer, unintentional use error related to patient condition caused or contributed to this event.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that: "within 3 minutes of placement of mac catheter, patient had an anaphylactic shock.As the anaesthesia staff and or team were made aware that the patient had a chlorhexidine allergy this morning, they did not use any subsidiary chlorhexidine products (mouth scubs, sage cloths, etc).However, the patient did use chlorhexidine wipes at home the night before and had hives on his skin when he arrived to pre-op (which is when they became aware of his allergy).Anaesthesia was not aware that the mac catheter was impregnated with chlorhexidine silver-sulfadiazine so it was used.Patient coded before the chest was cracked open and patient was put in a balloon pump.Additional information: anaphylactic shock to asystole cardiac arrest intraop.Patient treated with pepsid, benadryl, and steroid.The patient was stabilized after they opened the chest.Treatment after anaphylactic reaction: acls, cpr, steroids, ivf, intubation, and icu.Patient is extubated, awake, communicative, and on 2l o2 currently.Has returned to baseline with wheezing.".

• Brand Name: ARROW MULTI-LUMEN/PSI KIT
• Common Device Name: INTRODUCER 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: 20320018
• Report Number: 9680794-2024-00950
• Device Sequence Number: 7678756
• Product Code: DYB
• UDI-Device Identifier: 30801902122262
• UDI-Public: (01)30801902122262(11)240507(17)260110(10)33F24C0111(21)
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K011761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2024

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: 01/10/2026
• Device Catalogue Number: AK-21242-X
• Device Lot Number: 33F24C0111
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Supplement Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 10/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2024
• 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: NOT REPORTED; NOT REPORTED
• Patient Age: 64 YR
• Patient Sex: Male