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

Model Number 98432

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

Avanos medical inc.Received a single report that referenced multiple different incidences, which were associated with separate units, involving multiple different patients.This is the fourth of four reports.Refer to 9611594-2023-00141 for the first report.Refer to 9611594-2023-00142 for the second report.Refer to 9611594-2023-00143 for the third report.It was reported, "publication of a 10-year study (700 fittings) carried out by our team of paediatric gastroenterologists, highlighting a 20% rate of occurrence of adverse events (all minor) (e.G.Minor infections, staple exteriorisation) associated with gastrostomy introducer kits." no medical interventions were reported.Per additional information received on 9sep2023, ¿period of occurrence 2010-2020.¿ period of occurrence 2010-2020 publication of a 10-year study (700 poses) carried out by our team of pediatric gastroenterologists and putting in evidence a rate of occurrence of adverse effects (all minor) of 20% (eg granulomas, minimal infections, externalization of staples) related to gastrostomy introduction kits.Jean-bart c, c., aumar, m., ley, d.Et al.Complications of one-step button percutaneous endoscopic gastrostomy in children."eur j pediatr 182, 1665¿1672 (2023).Https://doi.Org/10.1007/s00431-023-04822-7.

Manufacturer Narrative

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.A root cause could not be determined.All information reasonably known as of 27 sep 2023 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 reported event but is relaying the information provided by the user facility where the incident occurred.This product incident is documented in the avanos medical 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.H3 other text : device not returned.

• Brand Name: INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE
• 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: 17857914
• MDR Text Key: 324840405
• Report Number: 9611594-2023-00144
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 00350770984322
• UDI-Public: 00350770984322
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K080253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 98432
• 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: 09/04/2023
• 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