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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX ARROW EPIDURAL

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TELEFLEX ARROW EPIDURAL Back to Search Results
Lot Number 23F21J0015
Device Problem Disconnection (1171)
Patient Problem Pain (1994)
Event Date 12/04/2021
Event Type  malfunction  
Event Description
Pt for induction of labor. Epidural placed at 1330. At 2200 patient stated she could feel pain. Nursing assessment found the patient's epidural catheter had become disconnected from the tubing requiring a new epidural be replaced.
 
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Brand NameARROW EPIDURAL
Type of DeviceARROW
Manufacturer (Section D)
TELEFLEX
morrisville NC 27560
MDR Report Key13059537
MDR Text Key282786173
Report Number13059537
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 12/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number23F21J0015
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 FDA12/06/2021
Distributor Facility Aware Date12/06/2021
Event Location Hospital
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/17/2021 Patient Sequence Number: 1
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