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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; CATHETER, CONDUCTION, ANESTHETIC

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TELEFLEX INCORPORATED ARROW; CATHETER, CONDUCTION, ANESTHETIC Back to Search Results
Model Number IPN045607
Device Problems Break (1069); Difficult to Remove (1528)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/06/2020
Event Type  malfunction  
Event Description
Epidural placed by anesthesia for labor patient.After delivery nurse attempted to remove catheter but met resistance, called anesthesia who came to the bedside.While attempting removal of catheter, piece broke off of end and remained in patients back.
 
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Brand Name
ARROW
Type of Device
CATHETER, CONDUCTION, ANESTHETIC
Manufacturer (Section D)
TELEFLEX INCORPORATED
po box 12600
durham NC 27709
MDR Report Key10074467
MDR Text Key191559974
Report Number10074467
Device Sequence Number1
Product Code BSO
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 04/23/2020,04/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberIPN045607
Device Catalogue NumberAK-05502
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/23/2020
Date Report to Manufacturer05/20/2020
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age9125 DA
Patient Weight90
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