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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW ENDURANCE PERIPHERAL CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

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ARROW ENDURANCE PERIPHERAL CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 22GA 8CM CATHETER
Device Problems Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/26/2021
Event Type  Injury  
Event Description
Picc nurse attempted to insert 22ga 8 cm endurance peripheral catheter into the cephalic vein. Blood return was noted. The procedure was aborted due to resistance when advancing the catheter. When removing the catheter it was noted that 2 cm was retained in the superficial sq tissue. The patient was taken to the ed for removal. No harm to patient. The catheter was given to representative: (b)(4). Fda safety report id# (b)(4).
 
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Brand NameARROW ENDURANCE PERIPHERAL CATHETER
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
MDR Report Key12664933
MDR Text Key277770332
Report NumberMW5104764
Device Sequence Number1
Product Code FOZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 10/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number22GA 8CM CATHETER
Device Catalogue Number22GA 8CM CATHETER
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2021
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/19/2021 Patient Sequence Number: 1
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