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	04/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: the patient underwent placement of a gastrostomy button on (b)(6) 2022, while hospitalized.She was discharged from the hospital on (b)(6).On (b)(6), the parent stated that he had found the child's button externalized and was able to tell that it had a punctured balloon.He was instructed to replace the device back into the hole right away so that the hole would not close and to keep it fixed in place with tape until a new device arrived to make the change.On (b)(6), the patient exchanged the device, so that the defective device can be returned for analysis.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.There were no deviations and no non-conformances initiated with this lot code.The actual sample involved in the reported incident was not returned for evaluation.No additional information, photographs or videos were received.Consequently, it was not possible to evaluate it as part of a comprehensive failure investigation and confirm the reported condition.The root cause and action plan will be documented through a formal corrective/preventative action (capa) which has been initiated 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. section d4: per the investigation site, the lot number originally reported as 1924101184 is not a valid lot number and the actual lot number is 1924101164 therefore the lot number has been updated. .
Additional Manufacturer Narrative
One decontaminated device within the original packaging and lot 1924101164 was received for evaluation.A visual inspection was performed according to procedure.Additionally, a functional test was conducted by inflating the balloon with water and a leak was detected in the tubing of the balloon, but there was no rupture found in the balloon.The root cause and action plan will be documented through a formal corrective/preventative action (capa) which has been initiated 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 14FR X 2.0CM
• 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 ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 14281681
• Report Number: 9612030-2022-03236
• Device Sequence Number: 20464976
• 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): 09/12/2022

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: 05/02/2022
• Supplement Date Received by Manufacturer: 05/02/2022; 05/02/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 06/06/2022; 09/12/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Female