MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 14FR EN; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	8884715148E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Purulent Discharge (1812); Skin Inflammation/ Irritation (4545); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that the connector cracked causing it to leak.The device had to be changed.There was no patient injury and no additional time for the intervention.
Additional Manufacturer Narrative
Section g3 has been updated to reflect the correct aware date of november 14, 2021.
Event or Problem Description
The customer reported that the connector cracked causing it to leak.The device had to be changed.There was no patient injury and no additional time for the intervention.Additional information received on december 31, 2021 stated that the device was placed on (b)(6) 2021 and on (b)(6) 2021, a problem was noticed at the level of the opening of the tubing.The plug did not fit because the screw to close the plug was broken and the tubing seems to remove itself upon ventral contraction.Purulent irritation and burns were noticed on the right flank due to stomach acid leakage.The tubing was removed and exchanged that day.On (b)(6) 2021, the plug was removed and light bloody secretions were noticed around the percutanea endoscopic gastrostomy.On (b)(6) 2021, the patient was sent to the hospital of vitré and the tubing was exchanged with another gastrotomy tube of the same item code.
Additional Manufacturer Narrative
Additional information added to the following sections: b3, b4, b7, h6.

• Brand Name: GSTRO FEED TBE W/Y PRT 14FR EN
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• 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: 12813621
• Report Number: 9612030-2021-03089
• Device Sequence Number: 4756777
• Product Code: PIF
• UDI-Device Identifier: 10884521661639
• UDI-Public: 10884521661639
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2022

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 Model Number: 8884715148E
• Device Catalogue Number: 8884715148E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 11/14/2021; 11/14/2021
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 11/29/2021; 01/13/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown