MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW LBCVC KIT: 3-L 12 FR X 20 CM ANTIMICROBI; CATHETER,INTRAVASCULAR,THERAP

Catalog Number CDC-25123-X1A

Device Problem Biocompatibility (2886)

Patient Problems Fatigue (1849); Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914); Rash (2033); Tachycardia (2095)

Event Date 12/04/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Patient with known sulfa allergy developed a severe rash throughout body and face after catheter in kit was placed.It was reported the packaging on the kit states it contains sulfa drugs, but it is listed in small print.Patient presented with complaint of fatigue, weakness and itchy rash for a few days.He was found to be hypotensive and tachycardiac on presentation.Additionally, he had leukocytosis and lactic acidosis which initially raised suspicion for septic shock.Given the allergic features of his presentation and the negative infectious workup, an allergic/anaphylactic process was considered.His symptoms started shortly after a new left subclavian tunneled catheter was placed and a bacitracin ointment was used as part of anti septic protocol for hemodialysis.He was started on levophed and broad spectrum antibiotics and was given hydrocortisone.Once the catheters were removed that had the coating his symptoms improved.Later placement of a non-coated cath was arranged and the patient had a short course of hemodialysis and was discharged.

Event Description

Patient with known sulfa allergy developed a severe rash throughout body and face after catheter in kit was placed.It was reported the packaging on the kit states it contains sulfa drugs, but it is listed in small print.Patient presented with complaint of fatigue, weakness and itchy rash for a few days.He was found to be hypotensive and tachycardiac on presentation.Additionally, he had leukocystosis and lactic acidosis which initially raised suspicion for septic shock.Given the allergic features of his presentation and the negative infectious workup, an allergic/anaphylactic process was considered.His symptoms started shortly after a new left subclavian tunneled catheter was placed and a bacitracin ointment was used as part of anti septic protocol for hemodialysis.He was started on levophed and broad spectrum antibiotics and was given hydrocortisone.Once the catheters were removed that had the coating his symptoms improved.Later placement of a non-coated cath was arranged and the patient had a short course of hemodialysis and was discharged.

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 report of an allergic reaction was confirmed by the event details of the reported complaint.The patient was confirmed to have allergies to sulfa drugs.Sulfa drugs are included in the coating of the catheter in this kit.The ag insert warns the user, "use of the arrow+gard blue antimicrobial catheter technology is contraindicated for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine and/or sulfa drugs." the instructions for use (ifu) provided with this kit also warns, "the arrowg+ard antimicrobial surface catheter is contraindicated for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine, and/or sulfa drugs.Arrowg+ard antimicrobial surface has been reported to cause hypersensitive reactions in japanese patients." based on the information provided, unintentional use error (patient condition) likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW LBCVC KIT: 3-L 12 FR X 20 CM ANTIMICROBI
• Type of Device: CATHETER,INTRAVASCULAR,THERAP
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 13151320
• MDR Text Key: 283141601
• Report Number: 9680794-2022-00002
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CDC-25123-X1A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2021
• 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
• Patient Age: 29 YR
• Patient Sex: Male