MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 16 CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number CS-22703-E

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Anaphylactic Shock (1703)

Event Date 02/04/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was used contrary to ifu.Contradiction: the device is contraindicated for patients with known hypersensitivity to chlorhexidine, silver sulfadiazine and/or sulfa drugs.

Event Description

The customer reports: the patient is chlorhexidine allergic and the anesthesiologist used a cvc arrowgard with chlorhexidine.The patient had an anaphylactic reaction and needed a reanimation.The patient's current condition is reported as fine.

Event Description

The customer reports: the patient is chlorhexidine allergic and the anesthesiologist used a cvc arrowgard with chlorhexidine.The patient had an anaphylactic reaction and need a reanimation.The patient's current 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 based on sales history and no relevant findings were identified.Based on the report that the patient had a chlorahexadine allergy and a device containing chlorahexadine was used, intentional user error caused or contributed to this event.The ifu provided with this kit states, "the arrowg+ard blue antimicrobial catheter is contraindicated for patients with known hypersensitivity to chlorhexidine acetate, silver sulfadiazine, and/or sulfa drugs" the customer was provided a letter explaining this event and has confirmed receipt.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 16 CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8371265
• MDR Text Key: 137178769
• Report Number: 3006425876-2019-00169
• 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: 02/13/2019

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 Catalogue Number: CS-22703-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/13/2019
• Initial Date FDA Received: 02/26/2019
• Supplement Dates Manufacturer Received: 04/02/2019
• Supplement Dates FDA Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR