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

Model Number	714120
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported they were having issues with excessive leakage and when they removed the device, they found it to have a very lopsided balloon.They tried to massage the balloon to see if it would go to a normal shape but it does not seem to.The device was inserted on (b)(6) 2021 and removed on (b)(6) 2021.Additional information received on 24-nov-2021 stated that the leakage was at the stoma site (around the skin level device).Leakage was a combination of formula, gastric contents etc.
Additional Manufacturer Narrative
Additional information: investigation summary: 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.All associated lot documentation was carefully reviewed.No issues or discrepancies were found related to the reported complaint.No non-conformities nor deviations related to leak or issue in the balloon were reported for this lot.Sample analysis could not be performed because no photo or samples were available for evaluation.The complaint will be reopened if a sample is received later.The reported condition could not be confirmed.Based on the present information, the reported condition could not be confirmed as related to the manufacturing process.The root cause could not be determined.No action plan could be determined.The current process controls are executed in accordance with product specifications to meet quality acceptance criteria.The manufacturing site will continue to monitor the process, customer complaints and feedback notifications for any adverse trends that require immediate attention.In case of a repeated issues and/or recurrence, a new investigation for the specific events would be carried out for each case.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
H3 sample evaluation.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.All associated lot documentation was carefully reviewed.No issues or discrepancies were found related to the reported complaint.No non-conformities nor deviations related to leak or issue in the balloon were reported for this lot.One decontaminated nutriport balloon was received for evaluation.The visual inspection was performed according to procedure.In addition, a functional test was performed.A leak was observed in the balloon.The reported condition is confirmed.A supplier corrective action request (scar) was generated to the balloon supplier.Corrective and preventative action will be taken by the supplier through the scar.This complaint will be used for tracking and trending purposes.

• Brand Name: BALLOON SLG 14 FR X 1.2 CM
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• 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 ; 5086183840
• MDR Report Key: 12984675
• Report Number: 9612030-2021-03118
• Device Sequence Number: 17461581
• Product Code: KNT
• UDI-Device Identifier: 10884521010635
• UDI-Public: 10884521010635
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 714120
• Device Catalogue Number: 714120
• Device Lot Number: 1812883764
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 11/24/2021; 11/24/2021
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 01/20/2022; 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown