MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; ANESTHESIA CONDUCTION KIT

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.".

• Brand Name: ARROW
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 10487454
• MDR Text Key: 205480762
• Report Number: 10487454
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: IPN045608
• Device Catalogue Number: AK-05503
• Device Lot Number: 23F20D0144
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/19/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 8760 DA
• Patient Weight: 98