MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-27702-E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Respiratory Arrest (4461)

Event Date 11/16/2023

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that: (b)(6) 2023, the doctor found the patient was in shock, respiratory arrest, and emergency resuscitation conditions during catheter use.After that cvc removal and rescue medication treatment.The patient condition is fine.Additional information has been requested from the account.A follow up report will be submitted after investigation.

Event Description

It was reported that: (b)(6) 2023, the doctor found the patient was in shock, respiratory arrest, and emergency resuscitation conditions during catheter use.After that cvc removal and rescue medication treatment.The patient condition is fine.

Manufacturer Narrative

(b)(4).The complaint of catheter related allergic reaction could not be confirmed.No sample was returned for investigation.The customer did not report that allergy testing was performed to confirm a chlorhexidine allergy.The instructions for use (ifu) provided with this kit warns the user, "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." a device history record review was performed, and no relevant findings were identified to suggest a manufacturing related issue.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: CVC SET: 2-LUMEN 7 FR X 20 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: 18318556
• MDR Text Key: 330383261
• Report Number: 3006425876-2023-01239
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801902102362
• UDI-Public: 00801902102362
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K900263
• 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: 11/16/2023

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 Operator: Health Professional
• Device Catalogue Number: CS-27702-E
• Device Lot Number: 71F23A2872
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 12/21/2023
• Supplement Dates FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2023
• 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