MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 18FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720189
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer stated the balloon was broken.
Additional Manufacturer Narrative
Additional information: h4 device manufacture date added device evaluation: the device history record (dhr) was reviewed showing no discrepancy according to the failure mode reported.One sample was received for evaluation.This is a component supplied by an external supplier.A complaint notification and the returned sample was sent to the provider to initiate the investigation.The reported issue was confirmed.Upon evaluation, the balloon was verified to have a pinhole that prevented the inflation of the balloon.It¿s unknown how the pinholes could have formed because all devices are inspected in the manufacturing processes at the supplier¿s site, including a 100% balloon inflation inspection for a minimum duration where any failures would be identified and segregated accordingly.The definitive root cause cannot be determined.Current controls are in place which include training and certification of all production personnel and quality inspectors.Line clearances are performed and documented at each workstation.All molds, presses, and testing equipment used to manufacture the product line are documented within device history records and cleaned and calibrated when applicable.Controls surrounding the actual silicone material used include stringent storage, milling, cleaning, and extrusion rules.Detailed pictorial instructions are present at each workstation and deliver specific guidance for every step of the manufacturing process.To mitigate the risk of releasing devices with balloon issues, each unit is 100% tested during the process, where it is inflated and inspected visually prior to accepting the unit for distribution.Additionally, quality control inspects to verify the integrity of the balloon.The production floor contains pictures, reminders, and icons that no sharp objects are acceptable around workstations where the cuff bonding or testing occurs.With all the controls in place through the manufacturing process, this limits the risk of releasing nonconforming products.No actions are warranted at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: GSTRO FEED TBE W/Y PRT 18FR
• 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: 15543047
• Report Number: 9612030-2022-03414
• Device Sequence Number: 5862433
• Product Code: KNT
• UDI-Device Identifier: 10884521007284
• UDI-Public: 10884521007284
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2022

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
• Operator of Device: Health Professional
• Device Model Number: 8884720189
• Device Catalogue Number: 8884720189
• Device Lot Number: 2106834864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 10/05/2022
• Supplement Report FDA Received Date: 12/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown