MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 4-LUMEN 8.5FR X 20CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number CS-45854-HP

Device Problem Insufficient Information (3190)

Patient Problems Anaphylactic Shock (1703); Erythema (1840); Itching Sensation (1943)

Event Date 04/23/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: patient was going to operating theatres for a cardiac procedure.The patient had im midazolam on the ward then iv midazolam in the anesthetic bay.Skin had been prepped using chg wipe and chg cvc was inserted in anesthetic bay.Within minutes of line being put in the patient started getting sever itchy red skin over trunk, arms and legs.The patient became tachycardic and low-grade fever.Line was removed and anaphylaxis treatment response protocol was initiated, and procedure cancelled.Patient was transferred to icu where he remained for 24hrs.Symptoms resolved, and patient was discharged.Allergy testing is pending.The patient had no known allergies.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.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

The customer reports: patient was going to operating theatres for a cardiac procedure.The patient had im midazolam on the ward then iv midazolam in the anesthetic bay.Skin had been prepped using chg wipe and chg cvc was inserted in anesthetic bay.Within minutes of line being put in the patient started getting sever itchy red skin over trunk, arms and legs.The patient became tachycardic and low-grade fever.Line was removed and anaphylaxis treatment response protocol was initiated, and procedure cancelled.Patient was transferred to icu where he remained for 24hrs.Symptoms resolved, and patient was discharged.Allergy testing is pending.The patient had no known allergies.

• Brand Name: ARROW CVC KIT: 4-LUMEN 8.5FR X 20CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10042646
• MDR Text Key: 190483247
• Report Number: 3006425876-2020-00412
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• 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: 04/27/2020

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: 10/09/2021
• Device Catalogue Number: CS-45854-HP
• Device Lot Number: 71F19L1133
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/27/2020
• Initial Date FDA Received: 05/11/2020
• Supplement Dates Manufacturer Received: 06/11/2020
• Supplement Dates FDA Received: 06/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 57 YR