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U.S. Department of Health and Human Services

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

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TELEFLEX MEDICAL 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
Manufacturer (Section D)
TELEFLEX MEDICAL
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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