MAUDE Adverse Event Report: COVIDIEN EPUMP/JOEY 500ML DEHP FEEDFLSH; PUMP, INFUSION, ENTERAL

Model Number	674668
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The customer reported that the water is leaking from the bottom.There was no patient harm reported.
Event or Problem Description
The customer reported that the water is leaking from the bottom.There was no patient harm reported.Additional information was provided by the customer and it was stated that the leak was noticed at the bottom of the flush bag, where the tubing joins the bag.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A sample was not received for the investigation, as it has been discarded.However, a picture was provided for the investigation.Upon analysis, the reported condition was not confirmed.Because a physical sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.A corrective action is not applicable at this time.The current process is running according to product specifications, meeting all quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: EPUMP/JOEY 500ML DEHP FEEDFLSH
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10711249
• Report Number: 1282497-2020-09551
• Device Sequence Number: 3899258
• Product Code: LZH
• UDI-Device Identifier: 10884521072282
• UDI-Public: 10884521072282
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2021

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
• Operator of Device: No Information
• Device Model Number: 674668
• Device Catalogue Number: 674668
• Device Lot Number: 182430163
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 10/19/2020; 10/19/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 10/21/2020; 01/11/2021
• Patient Sequence Number: 1