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

Model Number 718400

Device Problem Deflation Problem (1149)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/20/2022

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event 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.

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.

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
• Type of Device: 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
• MDR Text Key: 300706598
• Report Number: 9612030-2022-03266
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521011205
• UDI-Public: 10884521011205
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• 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
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Weight: 52 KG