MAUDE Adverse Event Report: TELEFLEX MEDICAL/TELEFLEX LLC (NADC 2) FLEXTIP PLUS EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION KIT

Model Number AK-05502

Device Problems Break (1069); Device Slipped (1584); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/13/2023

Event Type  malfunction  

Event Description

Per discussion with anesthesiologist, the rn exerted higher than normal traction when removing the epidural catheter causing it to snap.Per discussion with the rn involved, the catheter fell out as she was removing the dressing tape.Anesthesiologist believes the tip of the epidural catheter remains in the patient; x-ray confirmed no radiopaque foreign body present.Anesthesiologist contacted manufacturer of the kit, who let him know that they should have done a ct scan instead to confirm whether or not the tip was retained.

• Brand Name: FLEXTIP PLUS EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): TELEFLEX MEDICAL/TELEFLEX LLC (NADC 2)
• MDR Report Key: 17039764
• MDR Text Key: 316444204
• Report Number: MW5118021
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AK-05502
• Device Catalogue Number: AK-05502
• Device Lot Number: 33F23D0021
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Sex: Female
• Patient Weight: 70 KG