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 02/28/2022

Event Type  malfunction  

Event Description

Customer reports: the gastrostomy tube comes out as the balloon deflates.The probe output occurred 28/02/2022.The ball is inflated every eight days to prevent the balloon from deflating.

Manufacturer Narrative

Comment - 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

The device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.A sample analysis could not be performed since no photo samples nor actual sample device was received for evaluation.The root cause could not be determined without a sample to evaluate.The investigation was carried out with a multifunctional team, and the findings were that all processes and controls were found to be followed according to procedure, including packaging and all inspections performed on the product.No abnormal conditions were found that could trigger the reported condition.A risk assessment was carried out to determine the observed occurrence for this failure mode.Based on the analysis, the observed occurrence of harm (o) is (3, occasional) which is below the range of the expected occurrence of harm (o) (5, frequent).Therefore, no action plan is required at this point.This complaint shall be reopened if a sample is received.

• 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: 14497260
• MDR Text Key: 300440161
• Report Number: 9612030-2022-03263
• 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: 07/27/2022

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: 8884720221E
• Device Catalogue Number: 8884720221E
• Device Lot Number: 2120856464
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 05/25/2022
• Supplement Dates Manufacturer Received: 05/19/2022
• Supplement Dates FDA Received: 07/27/2022
• 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