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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. / TELEFLEX FLEX TIP PLUS EPIDURAL CATH KIT ANESTHESIA CONDUCTION KIT

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ARROW INTERNATIONAL, INC. / TELEFLEX FLEX TIP PLUS EPIDURAL CATH KIT ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number SJ-05501
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 06/22/2018
Event Type  Injury  
Event Description
Labor patient had epidural inserted by crna without difficulty. No issues during labor and after vaginal delivery of healthy baby. When the ob rn went to remove the epidural catheter, it broke, with 5 inches remaining in the epidural space. Ob rn noted tip at end not intact and one inch of tubing without coating, only wire present.
 
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Brand NameFLEX TIP PLUS EPIDURAL CATH KIT
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL, INC. / TELEFLEX
reading PA 19605
MDR Report Key7658228
MDR Text Key113228584
Report NumberMW5078200
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 Voluntary
Reporter Occupation
Type of Report Initial
Report Date 06/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2018
Device Catalogue NumberSJ-05501
Device Lot Number23F17K0443
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2018
Is the Reporter a Health Professional? Yes
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: 07/02/2018 Patient Sequence Number: 1
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