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

Model Number	775659
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date the device has not been received for evaluation.  if the device 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 or Problem Description
The customer reported that during the hydration of the patient by the sne, the feeding set presented a rupture in the silicone region.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on august 22, 2020.Samples were not received for the investigation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue.As a result, the root cause and potential corrective actions could not be identified at this time.This complaint will be closed with no further action; if a sample is received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.This complaint will be used for tracking and trending purposes.

• Brand Name: EPUMP SAFETY SCREW SPIKE SET
• Common Device Name: 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: 11813003
• Report Number: 1282497-2021-10174
• Device Sequence Number: 3910680
• Product Code: LZH
• UDI-Device Identifier: 10884521155831
• UDI-Public: 10884521155831
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2022

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: 775659
• Device Catalogue Number: 775659
• Device Lot Number: 202230347
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown