MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 22FR EN; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 8884720221E

Device Problem Unintended Deflation (4061)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2022

Event Type  malfunction  

Event Description

Customer reports: the gastrostomy tube comes out as the balloon deflates.The probe output occurred on (b)(6) 2022.The ball is inflated every eight days to prevent the balloon from deflating.

Manufacturer Narrative

The customer stated that the device will not be returned for evaluation but did not provide rationale.An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

Please disregard this report number (9612030-2022-03264).Further information provided by the customer stated that this complaint was initially reported as two events; one of which occurred on 3/19/22 and one event that occurred on 2/28/22.Upon further information provided by the initial reporter on 6/1/22, it has been determined that there was only one patient who experienced the same issue with the same device on two separate dates therefore, the event has already been reported on a previous 3500a report number (9612030-2022-03263).

• Brand Name: GSTRO FEED TBE W/Y PRT 22FR EN
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• 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: 14516156
• MDR Text Key: 300557557
• Report Number: 9612030-2022-03264
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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
• Report Date: 06/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884720221E
• Device Catalogue Number: 8884720221E
• Device Lot Number: 2120856464
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1