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

Model Number 775100

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2021

Event Type  malfunction  

Event Description

Customer reports: the set had a leak at the connection to the diet bag.

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.Updates were made to the 3500a form for the following fields: g1: contact name, email address, phone number g1: manufacturing site name g2: report source h3: device evaluated by manufacturer h4: labeled for single use h6: emdr section ¿ health effect/impact code, medical device problem code, type of investigation, investigation findings, investigation conclusions h10: additional manufacturer narrative.

Manufacturer Narrative

Investigation summary: 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.Since the sample was not provided for evaluation, the reported issue could not be confirmed and the root cause and corrective actions could not be identified.This complaint will be closed with no further action at this time.If a sample is received at a later date, the complaint will be reopened and updated accordingly.This complaint will be used for tracking and trending purposes.

• Brand Name: EPUMP 1000ML SAFETY SCREW SPIK
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12145432
• MDR Text Key: 263092412
• Report Number: 1282497-2021-10486
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521155817
• UDI-Public: 10884521155817
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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,Followup
• Report Date: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• 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: 203420055
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1