MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 20FR X 2.5CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 720250

Device Problem Unintended Deflation (4061)

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

Event Date 05/31/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the nurse stated the balloon emptied and came out of the patient while in use.

Manufacturer Narrative

The device history record (dhr) review was performed showing no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The sample was received, and a visual inspection and functional test was performed.The balloon was inflated with water and a leak was detected in the component.The reported condition was confirmed.The root cause of this issue will be determined by the supplier and documented under a corrective and preventative action (capa).This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

Additional information: h4 device manufacture date was added.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 reported condition.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 because no photo or sample was available for evaluation.The complaint will be reopened if a sample is received.The reported condition could not be confirmed.The root cause of this issue will be determined by the supplier and documented under a supplier corrective and preventative action this complaint will be used for tracking and trending purposes.

• Brand Name: BALLOON SLG 20FR X 2.5CM
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 04048
• 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: 14945426
• MDR Text Key: 303743563
• Report Number: 9612030-2022-03308
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 09/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 720250
• Device Catalogue Number: 720250
• Device Lot Number: 192882664
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2019
• Type of Device Usage: A
• Patient Sequence Number: 1