MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 24FR X 2.0CM; PUMP, INFUSION, ENTERAL

Model Number	724200
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that it is unknown if the device will be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
Customer reports: leaks in the inner balloon.It was the first time of use and it did not intervene with the patient.
Additional Manufacturer Narrative
Please disregard this report number as this report was inadvertently filed as a malfunction; based on the reported issue, despite several attempts for additional information, the customer did not provide enough information to determine a reportable product malfunction therefore an mdr should not have been generated.

• Brand Name: BALLOON SLG 24FR X 2.0CM
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 12482118
• Report Number: 9612030-2021-03040
• Device Sequence Number: 17201304
• Product Code: LZH
• UDI-Device Identifier: 10884521011410
• UDI-Public: 10884521011410
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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
• Operator of Device: No Information
• Device Model Number: 724200
• Device Catalogue Number: 724200
• Device Lot Number: 1916935364
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/09/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 11/03/2021
• Patient Sequence Number: 1