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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL ARROW; ANESTHESIA CONDUCTION KIT
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TELEFLEX MEDICAL ARROW; ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number IPN045747
Device Problem Difficult to Remove (1528)
Patient Problem Pain (1994)
Event Date 07/30/2018
Event Type  malfunction  
Event Description
Patient had interscalene block placed for management of post-operative pain.The patient was instructed to pull the catheter out on post-operative day 2.She was unable to remove the catheter and presented to the outpatient clinic.The anesthesiology team was unable to remove the catheter, as the patient complained of pain with mild traction.Concerned he would cause nerve injury, the anesthesiologist made an appointment for the patient to have it removed by interventional radiology.Interventional radiology was able to retrieve the catheter.It was intact with no kinking or other visible reason for it becoming stuck.We do not know why the catheter could not be removed.The catheter tip has coils and after removal, there was tissue embedded in the coils.
 
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Brand Name
ARROW
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
TELEFLEX MEDICAL
3015 carrington mill blvd
morrisville NC 27560
MDR Report Key7784122
MDR Text Key117148474
Report Number7784122
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 08/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberIPN045747
Device Catalogue NumberASK-19608-US1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/08/2018
Event Location Home
Date Report to Manufacturer08/15/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age11315 DA
Patient Weight56
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