MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CONTIPLEX TUOHY CONTINUOUS NERVE BLOCK SET; NERVE BLOCK CATHETER 18G X 4"

Catalog Number 331693

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Necrosis (1971); Pain (1994); Swelling (2091); Complaint, Ill-Defined (2331)

Event Date 12/14/2016

Event Type  Injury  

Event Description

Elective right total knee replacement on (b)(6) 2016.Post op developed increased pain, swelling and redness to right thigh.On (b)(6) 2016, pt return to operating room for necrotizing fasciitis of the right thigh musculature and fascial planes anteriorly and removal of hardware.

Event Description

Add'l info received from reporter on 02/02/2017 for mw5067007.Elective right total knee replacement on (b)(6) 2016 with insertion on continuous peripheral nerve block to right thigh adductor canal, post op in recovery room, same day.Post op day 1 ((b)(6) 2016) patient developed increased pain to right thigh.Post op day 2 ((b)(6) 2016) patient had worsening pain, swelling and redness to right thigh.Post op day 3 ((b)(6) 2016) nerve block discontinued.Post op day 4 ((b)(6) 2016) patient returned to operating room for necrotizing fascitis of the right thigh musculature and fascial planes anteriorly and removal of hardware.Soft tissue air in the anterior right thigh, most prominent along the surface of the quadriceps muscles, which may be within normal limits within several days after knee surgery.However, soft tissue infection, such as necrotizing fascitis, is difficult to exclude entirely.Correlation with clinical findings is suggested.On (b)(6) 2016 patient return to operating room for necrotizing fascitis of the right thigh musculature and fascial planes anteriorly and removal of hardware.On (b)(6) 2016 tissue culture and smear sent of right lateral thigh.Final results on (b)(6) 2016: positive for staphylococcus coagulase negative.On (b)(6) 2016 anaerobic culture sent of right thigh tissue/thigh.Final results on (b)(6) 2016: positive for propionibacterium acnes, necrotizing fascitis right lateral thigh.On (b)(6) 2016 return to operating room for (b)(6) of necrotic skin, subcutaneous fat, fascia and muscle involving anterior right thigh and abdomen.Wound vac placed.On (b)(6) 2016 return to operating room for (b)(6) of right lower abdomen and right lower extremity, application of integra, wound vac application.Contiplex continuous peripheral nerve block tray, ref (b)(4), product code cnb200tk, gtin (b)(4), unk lot and expiry date, (b)(4).Soft flex probe cover w/easy insert & gel 5' x 48" ref-20pc548, unknown lot and expiry date, (b)(4).High flexion articular insert/knee replacement device.Refer to voluntary medwatch report submitted on 12/29/2016 (b)(4).

• Brand Name: CONTIPLEX TUOHY CONTINUOUS NERVE BLOCK SET
• Type of Device: NERVE BLOCK CATHETER 18G X 4"
• Manufacturer (Section D): B. BRAUN MEDICAL INC. ; bethlehem PA 18018 3524
• MDR Report Key: 6217909
• MDR Text Key: 63851836
• Report Number: MW5067007
• Device Sequence Number: 0
• Product Code: MEB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/29/2016
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 331693
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 90