MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-22123-F

Device Problem Biocompatibility (2886)

Patient Problems Anaphylactic Shock (1703); Rash (2033)

Event Date 09/10/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Customer reports suspected allergic reaction to catheter.The cvc was placed at 14:10 and at 14:23 the patient had hypotension and high heart rate (bp 60/40, hr 150).The anesthesiologist was called and suspected anaphylactic shock.Rash was observed on the patient's body.The cause was suspected to be antibiotic or cvc.Vasopressors (levophed) were given and vital signs stabilized.The patient received ven*2amp (30+30mg), solucortef 100+100mg, and solu-medrol 40mg.A tee exam showed no rwma and a trpg was 11mmhg, no abnormality.Anti-allergy medications and supportive care given.The cvc was removed and a non-coated cvc was placed.The patient stayed in icu for close monitoring for one night.The patient's condition was reported to be stable and the patient was discharged from the hospital on (b)(6).

Event Description

Customer reports suspected allergic reaction to catheter.The cvc was placed at 14:10 and at 14:23 the patient had hypotension and high heart rate (bp 60/40, hr 150).The anesthesiologist was called and suspected anaphylactic shock.Rash was observed on the patient's body.The cause was suspected to be antibiotic or cvc.Vasopressors (levophed) were given and vital signs stabilized.The patient received ven*2amp (30+30mg), solucortef 100+100mg, and solu-medrol 40mg.A tee exam showed no rwma and a trpg was 11mmhg, no abnormality.Anti-allergy medications and supportive care given.The cvc was removed and a non-coated cvc was placed.The patient stayed in icu for close monitoring for one night.The patient's condition was reported to be stable and the patient was discharged from the hospital on (b)(6).

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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 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, silver sulfadiazine and/or sulfa drugs.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.Note: perform sensitivity testing to confirm allergy to catheter antimicrobial agents, if adverse reaction occurs." complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed based on a potential lot from sales history and no relevant findings were identified.Allergy testing was not performed to confirm that chlorhexidine, which is the antimicrobial coating on the catheter, was the cause of the allergic reaction.Therefore, the complaint cannot be confirmed and the root cause of this event cannot be determined based on the available information.Teleflex will continue to monitor and trend for reports of this nature.Corrected data: section d.1.-brand name corrected to arrow cvc set: 3-lumen 12 fr x 16 cm section d.2.-common device name corrected to catheter intravascular therape.Section d.4.-catalog# corrected to cs-22123-f.Section d.2.-procode corrected to foz.Section d.4.-udi# corrected to 00801902102188.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 16 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17906903
• MDR Text Key: 325308112
• Report Number: 3006425876-2023-00969
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801902102188
• UDI-Public: 00801902102188
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K993933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/13/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CS-22123-F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening