MAUDE Adverse Event Report: COVIDIEN BALLOON SLG 14 FR X 1.2 CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 714120

Device Problem Fluid/Blood Leak (1250)

Patient Problems Burn(s) (1757); Tissue Breakdown (2681)

Event Date 12/04/2020

Event Type  Injury  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.¿ as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that the patient was under management in conjunction with the wound clinic, from (b)(6) 2020 to (b)(6) 2020, due to peristomal leak and secondary burn.The patient is a (b)(6)-year-old male.Per customer, first they cleaned the peristomal tissue, the gastrostomy balloon was removed and a 12 fr foley catheter was inserted.The balloon was inflated with 5cc of water, the balloon remaining in the gastric chamber, after the peristomal skin was dried and protective powder was applied, an occlusive therapy was performed, and it was reinforced to facilitate closure in peristomal dilation.The product was working well, but when they re-insert the balloon, they identified rupture in the upper part of the balloon.Additional information received from the customer stated that it was not sure if the product was contributed to the peristomal lesion.The customer also confirmed that a nutrition leak was observed.The customer further stated that the patient had peristomal lesion secondary to a leakage.The patient required several dressings due to clinical wounds and ostomies.The balloon was used from (b)(6) 2020 to (b)(6) 2020.The patient was discharged on (b)(6) 2020 due to favorable clinical evolution, with a new gastrostomy button with adequate operation, without new leakage of content due to gastrostomy.

Manufacturer Narrative

The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One decontaminated sample was received for the evaluation.Upon visual evaluation, the reported condition was observed.However, based on the information provided by the customer, the gastrostomy was used for approximately 9 months, so the reported issue could not be confirmed as manufacturing related.In general, all process and controls were found properly followed, including sub-assemblies, finished product assembly, packaging and inspections performed to the product.There were no abnormal conditions found in the manufacturing process that could trigger the reported condition.Exact balloon life cannot be predicted, but the life span of the balloon varies according to several factors, which may include medications, balloon fill volume, gastric ph, and tube care.A kangaroo¿ skin level balloon can remain in a well-established gastrostomy for more than 30 days unless the tube comes out or becomes clogged.In such instances the patient should immediately contact the physician.As the reported issue could not be confirmed to be related to manufacturing/production process, no action plan is deemed required at this time.The current process is running according to product specifications meeting quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.Section b5 describe event or problem field has been corrected.

Event Description

The customer reported that the patient was under management in conjunction with the wound clinic, from (b)(6) 2020, due to peristomal leak and secondary burn.The patient is a 2-year-old male.Per customer, first they cleaned the peristomal tissue, the gastrostomy balloon was removed, 2% lidocaine was applied and a 12 fr foley catheter was inserted.The balloon was inflated with 5cc of water, the balloon remaining in the gastric chamber, after the peristomal skin was dried and protective powder was applied, an occlusive therapy was performed, and it was reinforced to facilitate closure in peristomal dilation.The product was working well, but when they re-insert the balloon, they identified rupture in the upper part of the balloon.Additional information received from the customer stated that it was not sure if the product was contributed to the peristomal lesion.The customer also confirmed that a nutrition leak was observed.The customer further stated that the patient had peristomal lesion secondary to a leakage.The patient required several dressings due to clinical wounds and ostomies.The balloon was used from (b)(6) 2020.The patient was discharged on (b)(6) 2020 due to favorable clinical evolution, with a new gastrostomy button with adequate operation, without new leakage of content due to gastrostomy.

• Brand Name: BALLOON SLG 14 FR X 1.2 CM
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 11340534
• MDR Text Key: 232338311
• Report Number: 9612030-2021-02800
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521010635
• UDI-Public: 10884521010635
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 714120
• Device Catalogue Number: 714120
• Device Lot Number: 2016111864
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/22/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2 YR