MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 18FR X 4.0CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	718400
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
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 there was a pinhole in the balloon and it deflated.There was no medical intervention required and no injury to the patient.
Additional Manufacturer Narrative
The device history record (dhr) review showed no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.A sample analysis could not be performed.The sample was shipped, but has been delayed in transit.The complaint will be reopened when the sample is received.This device is supplied by a supplier.The root cause of this issue will be determined by the supplier of the device and documented under a supplier corrective action report (scar).The corrective and preventive actions will be performed by the supplier and will be documented under the scar as well.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
One sample was received at the manufacturing site for evaluation.A visual inspection and a functional test was performed.A leak was observed in the balloon tube.The reported condition is confirmed.The root cause of this issue will be determined by our supplier and the results will be documented under the supplier¿s corrective and preventative action plan.This complaint will be used for tracking and trending purposes.

• Brand Name: BALLOON SLG 18FR X 4.0CM
• 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: 14546992
• Report Number: 9612030-2022-03266
• Device Sequence Number: 20063496
• Product Code: KNT
• UDI-Device Identifier: 10884521011205
• UDI-Public: 10884521011205
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/08/2022

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: 718400
• Device Catalogue Number: 718400
• Device Lot Number: 21048114064-I
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/26/2022
• Supplement Date Received by Manufacturer: 05/26/2022; 05/26/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 07/12/2022; 08/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Sex: Unknown
• Patient Weight: 52 KG