MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 14FR X 1.5CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 714150

Device Problem Break (1069)

Patient Problems Burn(s) (1757); Cellulitis (1768); Erythema (1840)

Event Date 02/28/2023

Event Type  malfunction  

Event Description

Customer reports: the tube was inserted on (b)(6) 2022 and the broken shaft was discovered on (b)(6) 2023 resulting in loss of feed and meds.Peristomal cellulitis and erythema and acid burn.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

The reported complaint stated that the tube was inserted on (b)(6) 2022 and broken shaft was discovered on (b)(6) 2023 resulting in loss of feed and meds.Peristomal cellulitis and erythema and acid burn.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.One decontaminated sample was received at the cardinal health site.A visual and functional inspection according to product specification was conducted.It was observed that the union part between the valve and the balloon tube is broken.The affected component is produced by an external supplier; our assembly process only consists of a pick and place operation for this material.The root cause and action plan were initiated to the supplier as a corrective action report (scar).A formal corrective/preventative action report (capa) has been opened to further investigate this issue.

Manufacturer Narrative

The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the condition reported by the customer.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.A sample analysis could not be performed since no photographs nor actual sample/s were received for evaluation.Based on the present information, and since no photo sample was provided and no actual sample was received; a possible root cause cannot be determined.The reported complaint could not be confirmed nor related to a manufacturing process.Based on historical review, a formal corrective/preventative action capa was generated to the supplier (scar) as corrective action of reported condition.

• Brand Name: BALLOON SLG 14FR X 1.5CM
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16587476
• MDR Text Key: 312290862
• Report Number: 9612030-2023-03649
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 714150
• Device Catalogue Number: 714150
• Device Lot Number: 2125709164
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1