MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 16 GA X 8"; CATHETER,INTRAVASCULAR,THERAP

Catalog Number CS-24301-E

Device Problem Insufficient Information (3190)

Patient Problems Anaphylactic Shock (1703); Numbness (2415); Chest Tightness/Pressure (2463)

Event Date 03/09/2020

Event Type  Injury  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

It was reported the catheter was inserted on the patient through the right internal jugular vein under local anesthesia.After successful catheterization, the patient immediately felt chest tightness and the body got numb.After consultation with several directors, the patient was examined, and it was considered that the antibacterial catheter in the neck caused the anaphylactic shock.Then removed the catheter in the neck, actively replenish fluid, resist arrhythmia, boost pressure, resist allergy, correct acid and correct water electrolyte balance.After the treatment, the patient's blood pressure was still low.Considering the patient's old age, gastrointestinal hemorrhage and coagulation dysfunction after the operation of malignant tumor.The patient was transferred to icu.Updated information indicates the patient's condition is reported as "fine".

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 provided with this kit contraindicates, "use of the arrowg+ard blue antimicrobial catheter technology is contraindicated for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine and/or sulfa drugs.Hypersensitivity reactions are a concern with antimicrobial catheters , in that they can be very serious and even life threatening".The customer did not state whether it was confirmed that the patient had a contraindication allergy.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.

Event Description

It was reported the catheter was inserted on the patient through the right internal jugular vein under local anesthesia.After successful catheterization, the patient immediately felt chest tightness and the body got numb.After consultation with several directors, the patient was examined, and it was considered that the antibacterial catheter in the neck caused the anaphylactic shock.Then removed the catheter in the neck, actively replenish fluid, resist arrhythmia, boost pressure, resist allergy, correct acid and correct water electrolyte balance.After the treatment, the patient's blood pressure was still low.Considering the patient's old age, gastrointestinal hemorrhage and coagulation dysfunction after the operation of malignant tumor.The patient was transferred to icu.Updated information indicates the patient's condition is reported as "fine".

• Brand Name: ARROW CVC SET: 16 GA X 8"
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10029636
• MDR Text Key: 190110818
• Report Number: 3006425876-2020-00396
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/21/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2020
• Device Catalogue Number: CS-24301-E
• Device Lot Number: 71F18E0728
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/21/2020
• Initial Date FDA Received: 05/06/2020
• Supplement Dates Manufacturer Received: 05/13/2020
• Supplement Dates FDA Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention