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	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the child was hospitalized at the (b)(6) hospital in (b)(6) and therefore lowered during the days after the procedure and on the seventh day after the surgery during the probe placement, which was performed with 4 ml of abd, the balloon break inside the child¿s organism, so the family immediately communicated the customer.Several attempts to gather information from the customer were made.To date, no response has been received.If additional pertinent information becomes available, the report will be updated.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the child was hospitalized at the children¿s hospital in belo horizonte and therefore lowered during the days after the procedure and on the seventh day after the surgery the patient was hospitalized for the probe placement, which was performed with 4 ml of abd, the balloon break inside the child¿s organism, so the family immediately communicated the customer.Additional information was received and stated that balloon broke with a clean tear (no fragmented pieces).
Additional Manufacturer Narrative
Section b5 has been updated to include additional information.
Additional 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.The device was manufactured on 22-july-2019.A sample was not received for the investigation.Because a sample was not returned, we were unable to perform a follow-up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.Since the affected component is provided by an external supplier, a corrective action (capa) has been generated to the supplier to determine the root cause and corrective and preventive actions, if required.This complaint will be used for tracing and trending purposes.
Additional 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.The device was manufactured on (b)(6) 2019.One sample was received for the analysis.Visual and functional test were performed.Upon performing the leak test, a rupture in the balloon was observed.Therefore, the reported issue was confirmed.Since the affected component is provided by an external supplier, a corrective action (capa) has been generated to the supplier to determine the root cause and corrective and preventive actions, if required.This complaint will be used for tracing 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; 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: 16773350
• Report Number: 9612030-2023-03678
• Device Sequence Number: 6386628
• Product Code: KNT
• UDI-Device Identifier: 10884521010635
• UDI-Public: 10884521010635
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 07/31/2023

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: 1919504664
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2023
• Supplement Date Received by Manufacturer: 04/10/2023; 04/10/2023; 04/10/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 04/26/2023; 06/14/2023; 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown