MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 14FR X 2.0CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	714200
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
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 that the button's balloon deflated and the button needed to be changed.
Additional Manufacturer Narrative
The device history record was reviewed.No abnormal process conditions were present during the manufacturing of the product that could have led to the reported issue.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.One decontaminated sample without original packaging from lot 1924101164 was received for evaluation.A visual inspection and functional test were performed.The balloon was inflated with water and a leak was detected from the balloon.The reported issue was confirmed.Since the device is provided by an external supplier, a notification was forwarded 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 device history record was reviewed.No abnormal process conditions were present during the manufacturing of the product that could have led to the reported issue.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Sample analysis could not be performed since no photos or physical samples were provided for evaluation.The complaint shall be reopened if a sample is received at a later date.A notification was forwarded the supplier of the reported component 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 14FR X 2.0CM
• 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: 15077455
• Report Number: 9612030-2022-03331
• Device Sequence Number: 17521825
• Product Code: KNT
• UDI-Device Identifier: 10884521010666
• UDI-Public: 10884521010666
• 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
• Report Date (Section B): 09/27/2022

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: 714200
• Device Catalogue Number: 714200
• Device Lot Number: 1924101164
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/19/2022
• Supplement Date Received by Manufacturer: 07/19/2022; 07/19/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 08/23/2022; 09/27/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown