MAUDE Adverse Event Report: CARDINAL HEALTH GSTRO FEED TBE W/Y PRT 22FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884720221
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/15/2022
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 they were treating a 16 year old female patient with a diagnosis of spastic cerebral palsy.They were having a problem with the balloon which was damaged.The device is removed.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.A sample analysis could not be performed because no photo or sample was available for evaluation.The complaint will be reopened if a sample is received.The reported condition could not be confirmed.The investigation was carried out with the multifunctional team.All processes and controls were found to be followed correctly, 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.The observed occurrence is below the range of the expected occurrence; therefore, no action plan is required at this point.This complaint will be used for tracking and trending purposes.

• Brand Name: GSTRO FEED TBE W/Y PRT 22FR
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• 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: 14218435
• Report Number: 9612030-2022-03233
• Device Sequence Number: 17490064
• Product Code: KNT
• UDI-Device Identifier: 10884521007321
• UDI-Public: 10884521007321
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2022

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: 8884720221
• Device Catalogue Number: 8884720221
• Device Lot Number: 2115220264
• 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: 04/12/2022
• Supplement Date Received by Manufacturer: 04/12/2022
• Initial Report FDA Received Date: 04/27/2022
• Supplement Report FDA Received Date: 05/23/2022
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Sex: Female