MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PICC KIT: 1-L 4.5 FR X 55 CM VPS; CATHETER, INTRODUCER

Catalog Number ASK-45541-UMM1

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

Patient Problems Anaphylactic Shock (1703); Nausea (1970); Dizziness (2194)

Event Date 12/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The customer reports: during the procedure for insertion of a picc the patient was oriented and alert.When the nurse was putting on the statlock, the patient claimed to be dizzy, hot, and wanted to vomit.The patient's eyes rolled back and became unresponsive.Patient developed a full body rash.Rapid response was called.Chest x-ray taken, and patient briefly came to but couldn't talk due to a swollen tongue.Medications were given through the picc and then the picc was pulled out of patient.The patient responded well to the medications and became conscious and responsive.Patient had no documented allergy to chlorhexidine.After 24 hours a non- protected picc was inserted and then the patient was discharged.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis and it could not be confirmed the patient had any contraindications.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, 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: during the procedure for insertion of a picc the patient was oriented and alert.When the nurse was putting on the statlock, the patient claimed to be dizzy, hot, and wanted to vomit.The patient's eyes rolled back and became unresponsive.Patient developed a full body rash rapid response was called.Chest x-ray taken, and patient briefly came to but couldn't talk due to a swollen tongue.Medications were given through the picc and then the picc was pulled out of patient.The patient responded well to the medications and became conscious and responsive.Patient had no documented allergy to chlorhexidine.After 24 hours a non- protected picc was inserted and then the patient was discharged.

• Brand Name: ARROW PICC KIT: 1-L 4.5 FR X 55 CM VPS
• Type of Device: CATHETER, INTRODUCER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8170855
• MDR Text Key: 130542883
• Report Number: 1036844-2018-00318
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: ASK-45541-UMM1
• Device Lot Number: 23F18J0341
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention