MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 12FR X 2.0CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	712200
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2022
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 that there was a rupture or leak in the balloon.Per additional information received on (b)(6) 2022, the rupture of the sealing balloon caused a leakage of the water filling it.Because of this, the probe could not be properly attached and had to be replaced.Per additional information received on (b)(6) 2022, there was no medical intervention given.The probe was replaced as part of the standard procedure.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported defect from customer complaint.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.One decontaminated nutriport balloon without its original packaging with lot 1812883764 was received for evaluation.The visual inspection was performed according to the procedure.In addition, a functional test was performed and a leak was observed in the balloon.The reported issue was confirmed.A corrective and preventive action has been initiated to determined the root cause and to address the reported issue.

• Brand Name: BALLOON SLG 12FR X 2.0CM
• 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: 14438384
• Report Number: 9612030-2022-03256
• Device Sequence Number: 14927070
• Product Code: KNT
• UDI-Device Identifier: 10884521010529
• UDI-Public: 10884521010529
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2022

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 Expiration Date: 10/31/2024
• Device Model Number: 712200
• Device Catalogue Number: 712200
• Device Lot Number: 1930921464
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown