MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 14 FR X 1.7 CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 714170

Device Problem Material Rupture (1546)

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

Event Date 07/31/2023

Event Type  malfunction  

Manufacturer Narrative

Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.

Event Description

Customer reports: the balloon burst on the sld.

Manufacturer Narrative

The device history record (dhr) review could not be performed since no lot number was provided from customer complaint report, and no photo/actual sample with an identifiable lot number was received.One decontaminated sample was received for evaluation.A visual inspection was performed according to procedure.Additionally, a functional test was performed.The leak test was performed by inflating the balloon and the reported condition was not observed.Based on historical data the supplier was issued a formal corrective/preventative action (capa).This complaint will be closed with no further action and will be used for tracking and trending purposes.

• Brand Name: BALLOON SLG 14 FR X 1.7 CM
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street, mansfield, ma; 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: 18124266
• MDR Text Key: 328035011
• Report Number: 9612030-2023-03856
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521010659
• UDI-Public: 10884521010659
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 714170
• Device Catalogue Number: 714170
• Device Lot Number: 2211010064
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1