MAUDE Adverse Event Report: AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 18FR DILATOR; DH EF PERC PLACEMENT PRODUCTS

Model Number 98431

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/05/2021

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of (b)(6) 2021 has been included in this health authority report.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 complaint database and identified as (b)(4).

Event Description

It was reported that a girl received an initial placement surgery for a mickey "two weeks ago" and while the procedure went well, the following day two of the three anchor sutures (saf-t-pexy) came loose.The patient was described as a child.There were no complications and the patient was discharged home.The patient was not injured and is doing well at home.Per additional information received (b)(6) 2021, the patient had a procedure on (b)(6) 2021 for initial placement of a 14fr/1.5cm mickey button.The following day during washing of the stoma site, one of the suture buttons came loose.An hour later, just before the patient returned home, a second suture button came off.It was reported "it does not come loose in the lock but the thread comes off.The lock is not particularly tight against the skin.The button was taped extra against the skin to reduce the risk of it going out.The last suture button is cut at home." there was no injury to the patient and no further medical treatment was required as a result of the event."the patient is feeling well.".

• Brand Name: INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 18FR DILATOR
• Type of Device: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (AVENT 1); circuito industial no.40; colonia obrera; nogales, cp 84048 ; MX 84048
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 13014254
• MDR Text Key: 283692290
• Report Number: 9611594-2021-00187
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 00350770984315
• UDI-Public: 00350770984315
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K080253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 98431
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2021
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: 14FR/1.5CM MICKEY BUTTON.
• Patient Age: 4 YR
• Patient Sex: Female
• Patient Weight: 12 KG