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U.S. Department of Health and Human Services

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

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TELEFLEX INCORPORATED ARROW CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number IPN036525
Device Problem Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/17/2021
Event Type  malfunction  
Event Description
Code team was attempting to insert a central line. During insertion it was determined that the clamp was defective. The central line had to be removed and restarted with a new kit.
 
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Brand NameARROW
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
TELEFLEX INCORPORATED
po box 12600
durham NC 27709
MDR Report Key12100529
MDR Text Key259443138
Report Number12100529
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberIPN036525
Device Catalogue NumberASK-46702-PWBH1
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/23/2021
Event Location Hospital
Date Report to Manufacturer07/01/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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