MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. LOCKIT PLUS REGIONAL ANAESTHESIA CATHETER SECUREMENT; CATHETER, CONDUCTION, ANESTHETIC

Catalog Number 100/399/218

Device Problem Contamination (1120)

Patient Problems Post Operative Wound Infection (2446); Patient Problem/Medical Problem (2688)

Event Date 08/19/2018

Event Type  Injury  

Event Description

It was reported that a (b)(6) year old patient developed a subcutaneous infection around the epidural insertion site.The skin infection was "possibly" related to use of the smiths medical product.An mri scan was performed to exclude epidural abscess/hematoma.The mri showed subcutaneous collection indicating an infection which was superficial to the epidural space.Antibiotics were prescribed to manage the infection.The patient was reported to be doing well, and was to be reviewed at an outpatient clinic for resolution of the infection, after the antibiotic course was finished.

• Brand Name: LOCKIT PLUS REGIONAL ANAESTHESIA CATHETER SECUREMENT
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL NORTH AMERICA; 10 bowman drive; keene OH 03431 0724
• Manufacturer Contact: dave halverson ; 1265 grey fox road; st. paul, MN 55112 ; 7633833310
• MDR Report Key: 7891743
• MDR Text Key: 120822380
• Report Number: 3012307300-2018-03743
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 100/399/218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2018
• Initial Date FDA Received: 09/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 YR