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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW ANESTHESIA CONDUCTION KIT

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TELEFLEX INCORPORATED ARROW ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number IPN045608
Device Problems Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/08/2020
Event Type  malfunction  
Event Description
Epidural was placed by anesthesiologist on august 8th at 6:04 pm. The patient was positioned sitting upright, local anesthesia lidocaine without epinephrine (1%), approach midline, needle (# 17 gauge, placed via loss of resistance technique (with air), catheter inserted into epidural space: 5 cm; insertion level: l3/4. Patient vaginally delivered baby at seven hours later [time redacted]. Three hours after delivery [time redacted], rn attempted to discontinue the epidural catheter, with patient sitting on the side of the bed, with feet dangling; she met resistance. Another rn came in and attempted to remove it but also met with resistance. Then the crna was called to the bedside, and she withdrew the catheter and it broke. Per the crna, the catheter snapped off, with the tip still in the patient's back; she stated the catheter felt "brittle," like it was sitting in the sun too long. An anesthesiologist came to the bedside and notes: "wire was still intact and protruding from insertion site. Patient was placed in right lateral position, skin prepped with chloraprep, draped sterile. Total 20 ml 2% lidocaine for skin and sub q local. 1. 5 inch incision made with 10 blade. Blunt retraction with artery forceps using army-navy to retract. Distal catheter visualized at the end of the wire. Catheter removed without difficulty. Tip found to be intact with no discontinuity of broken ends. Single deep suture with 3. 0 vicryl, subcutaneous monocryl, liquid glue and steristrips applied. ".
 
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Brand NameARROW
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
TELEFLEX INCORPORATED
po box 12600
durham NC 27709
MDR Report Key10487454
MDR Text Key205480762
Report Number10487454
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 08/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberIPN045608
Device Catalogue NumberAK-05503
Device Lot Number23F20D0144
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/19/2020
Event Location Hospital
Date Report to Manufacturer09/03/2020
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: 09/03/2020 Patient Sequence Number: 1
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