MAUDE Adverse Event Report: AVANOS MEDICAL HALYARD MIC JEJUNAL FEEDING TUBE; TUBES, GASTROINTESTINAL AND ACCESSORIES

Model Number 14 FR 7-10 ML

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Adhesion(s) (1695); Edema (1820); Tissue Damage (2104); Vomiting (2144); Obstruction/Occlusion (2422)

Event Date 01/07/2019

Event Type  Injury  

Event Description

On (b)(6) 2018 laparoscopy procedure changed into laparotomy and a graham patch and jejunostomy feeding tube inserted.After several days patient developed bilious emesis.Md took some fluid out of the balloon.On (b)(6) medical doctor attempted to remove all fluid from balloon.Pt.Continued emesis and an ng tube was placed.Contrast study showed small bowel obstruction near the j-tube site.On (b)(6) 2019 return to surgery, patient had edematous bowel very adherent to anterior abdominal wall and other pieces of bowel.It was difficult to locate the location of the j-tube.Medical doctor performed lysis of adhesions and take down of j-tube with small bowel resection and primary handsewn anastomosis; repair of small bowel serosal tear; repair of serosal colon injury form previous operation.Op report states that md made sure j-tube balloon was empty prior to prep and drape.Sutures were cut, and j-tube come out with some resistance and found there was still fluid inside the balloon.Md opines that the balloon itself was the cause of the obstruction.Removing the large balloon through the bowel created injury.The bowel was fully mobilized off the abdominal wall, this portion of the bowel was not salvageable.A small bowel resection and a handsewn anastomosis of the jejunojejunostomy to the common channel was performed, as this was the location of the tube in the injury.A small serosal tear of small bowel was oversewn.Ref mfr report # 9611594-2019-00029.

• Brand Name: HALYARD MIC JEJUNAL FEEDING TUBE
• Type of Device: TUBES, GASTROINTESTINAL AND ACCESSORIES
• Manufacturer (Section D): AVANOS MEDICAL; alpharetta GA 30004
• MDR Report Key: 8371312
• MDR Text Key: 137364231
• Report Number: MW5084366
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/04/2019

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 14 FR 7-10 ML
• Device Catalogue Number: 0200-14
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 70