MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTOFUSER; PUMP, INFUSION, ELASTOMERIC

Catalog Number MEDICAL UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Dyspnea (1816); Muscle Weakness (1967); Cough (4457)

Event Date 04/23/2023

Event Type  malfunction  

Event Description

It was reported via medwatch report, "i was given an arrow teleflex autofuser containing ropivacaine.I noticed shortness of breath which i was told was not a real symptom prior to use.It felt like my diaphragm was not moving properly.This continued for the 3 days i used the device.I finally stopped use due to the discomfort in my chest.I began heavy coughing about 2 hours after stopping.Coughing up a lot of sticky mucus.The installation of the device has also caused significant pain and muscle pain and spasm in my neck.I would never allow it's use on me again.Oxycodone or similar would have been fine and much less invasive and damaging.The medication caused numbness and pain in my hand that became serious at the '6' setting".Further information is not available from the customer.

Manufacturer Narrative

(b)(4).Medwatch report #mw5117069.Other remarks: n/a.Corrected data: n/a.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be performed as product information such as product code and lot number were not provided at time of report.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.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported via medwatch report, "i was given an arrow teleflex autofuser containing ropivacaine.I noticed shortness of breath which i was told was not a real symptom prior to use.It felt like my diaphragm was not moving properly.This continued for the 3 days i used the device.I finally stopped use due to the discomfort in my chest.I began heavy coughing about 2 hours after stopping.Coughing up a lot of sticky mucus.The installation of the device has also caused significant pain and muscle pain and spasm in my neck.I would never allow it's use on me again.Oxycodone or similar would have been fine and much less invasive and damaging.The medication caused numbness and pain in my hand that became serious at the '6' setting".Further information is not available from the customer.

• Brand Name: AUTOFUSER
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer Contact: marling heaton ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17006026
• MDR Text Key: 316791577
• Report Number: 3013162291-2023-00002
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: MEDICAL UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/04/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 07/03/2023
• Supplement Dates FDA Received: 07/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.