MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 12 FR X 1.7 CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	712170
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.
Event or Problem Description
Customer reports: the balloon on the sld burst.
Additional Manufacturer Narrative
The device history record (dhr) for each lot affected was review, showed that manufacturing and inspection product was performed as per applicable procedures and validated process.All inspection results were within acceptable criteria as per established sampling plan levels quality procedures.One decontaminated sample was received for evaluation.A visual inspection was performed according to procedure.Additionally, a functional test was performed.The leak test was performed by inflating the balloon and the reported condition was observed; a leakage was observed from a pinhole in the balloon.Based on historical data the supplier was issued a formal corrective/preventative action (capa) the root cause and action plan will be documented to address the reported condition to mitigate any further occurrences.This action is currently ongoing.This complaint will be closed with no further action and will be used for tracking and trending purposes.

• Brand Name: BALLOON SLG 12 FR X 1.7 CM
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street, mansfield, ma; 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: 18124477
• Report Number: 9612030-2023-03857
• Device Sequence Number: 20471412
• Product Code: KNT
• UDI-Device Identifier: 10884521010512
• UDI-Public: 10884521010512
• 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
• Report Date (Section B): 04/01/2024

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: 712170
• Device Catalogue Number: 712170
• Device Lot Number: 2129220864
• 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: 10/17/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 11/13/2023
• Supplement Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown