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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW EPIDURAL CATHETERIZATION KIT WITH FLEXTIP PLUS ANESTHESIA CONDUCTION KIT

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TELEFLEX INCORPORATED ARROW EPIDURAL CATHETERIZATION KIT WITH FLEXTIP PLUS ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number AK-05503
Device Problems Difficult to Remove (1528); Material Protrusion/Extrusion (2979); Physical Resistance/Sticking (4012)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/14/2019
Event Type  malfunction  
Event Description
Epidural catheter placed by anesthesiologist; he notes: "positioned sitting upright, approach midline, needle (# 17 gauge, placed via loss of resistance technique (saline), depth of epidural space: 7cm; catheter depth at skin: 10 cm; catheter inserted into epidural space:3 cm; insertion level: l2-3. " about 6 hours later, the patient delivered her baby vaginally. Post delivery the nurse tried to remove the catheter and met resistance, so she stopped. She called the charge rn who repositioned the patient, then attempted to pull out the catheter, but also met resistance and stopped. The crna was called. He attempted and when he pulled the catheter, it snapped/broke. At that point, the anesthesiologist was notified. He could see a bit of the catheter poking out under the skin, so he numbed the area and attempted to grasp the end of it from under the skin. He was unable to retrieve the cath, and because of the tension, it coiled back into the back. Afterwards, the anesthesiologist noted that there was no obvious problem with the catheter, and no visible knots on ct. He indicated that perhaps he could have removed it with some positioning techniques. For this reason, i do not believe this retained broken epidural catheter was caused by a catheter defect; but i did want the fda and manufacturer to be aware of this. The following day, the patient went to surgery and had the 7. 5 cm catheter piece removed from her back. It is available in our pathology department for inspection, but we will not be releasing it.
 
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Brand NameARROW EPIDURAL CATHETERIZATION KIT WITH FLEXTIP PLUS
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
TELEFLEX INCORPORATED
3015 carrington mill blvd
morrisville NC 27560
MDR Report Key9473947
MDR Text Key170913554
Report Number9473947
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 12/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberAK-05503
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/02/2019
Event Location Hospital
Date Report to Manufacturer12/16/2019
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

Patient Treatment Data
Date Received: 12/16/2019 Patient Sequence Number: 1
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