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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CONTINUOUS PERIPHERAL NERVE BLOCK KIT ANESTHESIA CONDUCTION KIT

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ARROW INTERNATIONAL INC. CONTINUOUS PERIPHERAL NERVE BLOCK KIT ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number ASK-19608-US1
Device Problem Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/15/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). Medwatch# (b)(4). The device sample has not been returned for investigation. Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that the patient had interscalene block placed for management of post-operative pain. The patient was instructed to pull the catheter out on post-operative day two. 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 NameCONTINUOUS PERIPHERAL NERVE BLOCK KIT
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key7902348
MDR Text Key121486246
Report Number1036844-2018-00246
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberASK-19608-US1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/16/2018
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

Patient Treatment Data
Date Received: 09/24/2018 Patient Sequence Number: 1
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