MAUDE Adverse Event Report: CARDINAL HEALTH EPUMP 1000ML SAFETY SCREW SPIK; PUMP, INFUSION, ENTERAL

Model Number	775100
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the set was leaking and the tube had air bubbles.There was no patient harm.
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Additional Manufacturer Narrative
Additional information h4 device manufacture date was added.Evaluation summary the device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and quality documentation.One used sample was received at the manufacturing site for evaluation.Visual inspection was performed, and no visual failure was found.Functional inspection could not be performed because the valve and the line are stuck with food.The sample is inadequate to be evaluated.No formal investigation action is being taken because the failure mode could not be confirmed related to the manufacturing/production process.No root cause could be determined.This complaint will be closed with no further action and will be used for tracking and trending purposes.
Additional Manufacturer Narrative
Investigation: the device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and quality documentation.Because the sample was not provided for evaluation, the failure mode could not be confirmed.The root cause and corrective actions could not be identified.This complaint will be closed with no further action.If a sample is received later, the complaint will be reopened for investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: EPUMP 1000ML SAFETY SCREW SPIK
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 13151210
• Report Number: 1282497-2022-10668
• Device Sequence Number: 4146073
• Product Code: LZH
• UDI-Device Identifier: 10884521155817
• UDI-Public: 10884521155817
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2022

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: 775100
• Device Catalogue Number: 775100
• Device Lot Number: 211160128
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/23/2021
• Supplement Date Received by Manufacturer: 12/23/2021; 12/23/2021
• Initial Report FDA Received Date: 01/04/2022
• Supplement Report FDA Received Date: 02/14/2022; 03/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown