MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 22FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720221
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Customer reports: the balloon was broken.On 09/09/22, per additional information, the balloon ruptured.
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 complaint.A sample analysis could not be performed since no photo nor actual samples were received for evaluation.Without a sample or photos evaluation, a possible root cause cannot be determined; conditions reported could not be confirmed.The manufacturing process was reviewed and determined that all process and controls were followed, including sub-assemblies, finished product assembly, packaging and inspections.There were no abnormal conditions found that could trigger the reported condition.A risk assessment was performed to determine the occurrence of the reported failure mode.Based on the above analysis, the observed occurrence of harm (0) is (3, occasional) which is below the range of the expected occurrence of harm (0) (5, frequent).The current process is running according to product specifications meeting quality acceptance criteria.We will continue monitoring the process for any adverse trends that require immediate attention.
Additional Manufacturer Narrative
The sample was returned to the manufacturing facility.The reported issue of balloon burst / rupture was confirmed.Upon evaluation, the balloon was verified having a tear that prevented the device from functioning as intended.Through a physical inspection using a microscope, a lighted magnifying glass, and unaided eye, the entire unit appeared in good functional condition besides the balloon damage.It was apparent that the device was used but the duration of the usage was not provided.When a device is used, the balloon cuff has discoloration and expanded to the extent the balloon cuff will not return to its normal unused condition.Knowing this detail, the unit seemed to have functioned as intended prior to the complaint.Nothing else was observed to be abnormal that would induce a device malfunction.These devices are not intended for permanent use and should be cared for and replaced as needed.No actions are warranted at this time.The supplier will continue to monitor for any trends.

• Brand Name: GSTRO FEED TBE W/Y PRT 22FR
• 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: 15398634
• Report Number: 9612030-2022-03382
• Device Sequence Number: 12306690
• Product Code: KNT
• UDI-Device Identifier: 10884521007321
• UDI-Public: 10884521007321
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/01/2023

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: 8884720221
• Device Catalogue Number: 8884720221
• Device Lot Number: 2115220264
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2022
• Supplement Date Received by Manufacturer: 08/26/2022; 08/26/2022
• Initial Report FDA Received Date: 09/12/2022
• Supplement Report FDA Received Date: 09/30/2022; 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown