MAUDE Adverse Event Report: COVIDIEN EPUMP SAFETY SCREW SPIKE SET; PUMP, INFUSION, ENTERAL

Model Number 775659

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/08/2021

Event Type  malfunction  

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.

Event Description

The customer reported during use they noticed the tube of the feeding set was cracked and leaking formula.There was no harm to the patient.

• Brand Name: EPUMP SAFETY SCREW SPIKE SET
• 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: 11715751
• MDR Text Key: 246983130
• Report Number: 1282497-2021-10101
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521155831
• UDI-Public: 10884521155831
• 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: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 775659
• Device Catalogue Number: 775659
• Device Lot Number: 202720435
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/13/2021
• Type of Device Usage: N
• Patient Sequence Number: 1