MAUDE Adverse Event Report: CARDINAL HEALTH POLYUR F T 8FRX20IN W ENFIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	461701E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that a nurse in the nicu found a defective orogastric (og) tube.Per additional information provided by the customer, the nurse pushed air into the og once it was inserted to ensure it was in the proper placement and could be heard in the stomach but was unable to hear the air.The rn removed the og tube from the patient and attempted to push water through the og at the sink area.The water passed easily through the tube but the base of the tube, that would be in the patient's stomach, was slightly bent so the rn assumed that was the issue.The nurse discarded and replaced the feeding tube with no issues.There was no patient harm and no change in the medical treatment/interventions given.
Additional Manufacturer Narrative
Investigation summary: the device history record (dhr) file was reviewed, and no discrepancy was found according to the failure mode reported.Physical sample was not returned.Photos of the packaging was provided however, based on the images it is not possible to confirm the reported condition.If a sample is received at a later date the investigation will be updated.The exact root cause could not be determined at this time.Functional inspection is performed during the manufacturing process with acceptable results according to quality standard requirements.No action plan is deemed required.The current process is running according to product specifications, meeting quality acceptance criteria.The manufacturing site will continue monitoring the process for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: POLYUR F T 8FRX20IN W ENFIT
• Common Device Name: 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: 12954490
• Report Number: 9612030-2021-03116
• Device Sequence Number: 14614356
• Product Code: PIF
• UDI-Device Identifier: 10884521547162
• UDI-Public: 10884521547162
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

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
• Operator of Device: Health Professional
• Device Model Number: 461701E
• Device Catalogue Number: 461701E
• Device Lot Number: 2125032964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/24/2021
• Supplement Date Received by Manufacturer: 11/24/2021
• Initial Report FDA Received Date: 12/07/2021
• Supplement Report FDA Received Date: 01/20/2022
• Date Device Manufactured: 09/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown