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

Model Number 8884715148E

Device Problem Fluid/Blood Leak (1250)

Patient Problems Purulent Discharge (1812); Skin Inflammation/ Irritation (4545); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2021

Event Type  malfunction  

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 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.

Manufacturer Narrative

Section g3 has been updated to reflect the correct aware date of november 14, 2021.

Event 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.

Manufacturer Narrative

Additional information added to the following sections: b3, b4, b7, h6.

• Brand Name: GSTRO FEED TBE W/Y PRT 14FR EN
• Type of Device: 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
• MDR Text Key: 281521726
• Report Number: 9612030-2021-03089
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• 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
• Date Manufacturer Received: 11/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1