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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC (SUBSIDIARY OF TELEFLEX, INC. FLEX TIP PLUS EPIDURAL CATHERIZATION KIT ANESTHESIA CONDUCTION KIT

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ARROW INTERNATIONAL, INC (SUBSIDIARY OF TELEFLEX, INC. FLEX TIP PLUS EPIDURAL CATHERIZATION KIT ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number AK-05502
Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/17/2019
Event Type  Injury  
Event Description
Epidural catheter was resistant to come out after a delivery via c-section. Two physicians arrived, and one attempted to remove the catheter. After initial progress the device broke. The physician informed the patient what had happened, and told her it would require surgery to remove the device. Fda safety report id# (b)(4).
 
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Brand NameFLEX TIP PLUS EPIDURAL CATHERIZATION KIT
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL, INC (SUBSIDIARY OF TELEFLEX, INC.
MDR Report Key8866187
MDR Text Key153648130
Report NumberMW5088825
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 Administrator/Supervisor
Type of Report Initial
Report Date 08/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2020
Device Catalogue NumberAK-05502
Device Lot Number23F19A0372
Was Device Available for Evaluation? Yes
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: 08/05/2019 Patient Sequence Number: 1
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