MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS - 18 FR; DH EF BALLOON TUBES PRODUCTS

Model Number 8100-18

Device Problems Break (1069); Migration (4003)

Patient Problem No Code Available (3191)

Event Date 03/17/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 11-jun-2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).

Event Description

An fda medwatch / fda user facility report # (b)(4) was received and the following information was provided: "patient had percutaneous endoscopic gastrostomy tube placement.Per the op note: "under endoscopic visualization 3 t-fasteners were placed percutaneously securing the anterior gastric wall against and to abdominal wall.A 1 cm incision was created between these fasteners and carried on down through the rectus fascia.An 18-gauge needle was placed through this incision followed by j-wire using seldinger technique.Under endoscopic visualization a large dilator and sheath was passed over the wire.The wire and the dilator was removed leaving the sheath in place.18 french g-tube was advanced through the sheath and the balloon was inflated with 10 cc of saline and brought back against and to abdominal wall." once he was tolerating tube feedings , he was discharged home three days after.The following morning , patient awoke with abdominal pain.In the ed, ct showed: "g-tube is noted positioned in the stomach.Note is made of punctate extraluminal air to the right of the g-tube tract with small amount of fluid also evident." once admitted to floor , as he was coming out of the bathroom, his g-tube unintentionally fell out of his abd and wound started bleeding.Surgeon consulted and noted: "the patient's peg tube fell out while he was in the bathroom.Reportedly the peg tube was not pulled on.We tested and the balloon was ruptured.The patient had a ct scan of the abdomen earlier today which i personally reviewed which demonstrated a small amount of air near the peg tube which i imagine is just because the balloon was not fully inflated." taken to or that evening, op note states the surgeon located the site of the prior gastrotomy and that "there was staining in the area and it was evident that this had been leaking some around where the tube was.This is a type 4 wound given the obvious hole in the stomach with some contamination." repair to old site completed with graham patch.Then new g-tube placed, stamm type.This surgeon actually put in 2 of these gastrostomy tubes on different patients in the same week.Both of them deflated and/or ruptured, and became dislodged, within 7 days of placement.We have pulled the remainder of this product from our stock for the time being.The surgeon would like to receive a copy of the manufacturer's final report.Thank you.What was the original intended procedure? : g-tube (gastrostomy tube) placed for tube feedings.What problem did the user have (check all that apply) :device failed (e.G.Broke, couldn't get it to wort or stopped working).Date of event: (b)(6) 2020.

Manufacturer Narrative

All information reasonably known as of 10-sep-2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical, inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical, inc.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical, inc.Product is defective or caused serious injury.

• Brand Name: MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS - 18 FR
• Type of Device: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10148482
• MDR Text Key: 195301432
• Report Number: 9611594-2020-00099
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770442938
• UDI-Public: 00350770442938
• Combination Product (y/n): N
• PMA/PMN Number: K842076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

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: 8100-18
• Device Catalogue Number: 104429300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/12/2020
• Supplement Dates Manufacturer Received: 08/28/2020
• Supplement Dates FDA Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 94