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

Model Number	8884720189
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the probe balloon breaks and must be changed by three different occasions for the same reason.They apparently have a defect in the batch used.
Additional 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 above analysis, the observed occurrence of harm (o) is (1, improbable) which is below the range of the expected occurrence of harm (o) (5, frequent).As part of the containment, a notification was issued to the production personnel to heighten awareness of the condition reported by customer.This complaint shall be reopened if a sample is received.

• 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: 15178249
• Report Number: 9612030-2022-03346
• Device Sequence Number: 6302084
• Product Code: KNT
• UDI-Device Identifier: 10884521007284
• UDI-Public: 10884521007284
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2022

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: 8884720189
• Device Catalogue Number: 8884720189
• Device Lot Number: 2028718364
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2022
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 08/05/2022
• Supplement Report FDA Received Date: 08/05/2022
• 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: Male