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

Model Number 775100

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 04/25/2021

Event Type  malfunction  

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 Description

Customer reports: a leak was observed in the connection thread to the pouch of an enteral feeding set.The device was removed and replaced.

• Brand Name: EPUMP 1000ML SAFETY SCREW SPIK
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 11765758
• MDR Text Key: 250985266
• Report Number: 1282497-2021-10145
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2021

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 Operator: No Information
• Device Model Number: 775100
• Device Catalogue Number: 775100
• Device Lot Number: 203560088
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/03/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1