MAUDE Adverse Event Report: COVIDIEN JOEY 1000ML PUMP SET; PUMP, INFUSION, ENTERAL

Model Number	763656
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported that the tubing is not connected all the way and there is a slight hole causing the bag to leak.There was no patient harm reported.
Additional Manufacturer Narrative
Investigation summary: the customer reported that the tubing is not connected all the way and there is a slight hole causing the bag to leak.There was no patient harm reported.A device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.Product lot and failure mode trend analysis did not identify a trend within the reported lot, nor for the reported failure mode.The reported device was not returned for evaluation, however, photographs were provided by the customer.Visual inspection of the photographs confirmed the device was leaking.The root cause is determined to be manufacturing/process related.A corrective action was initiated to replace the rf sealing machine.No further action is required at this time.This device issue will continue to be monitored and trended.

• Brand Name: JOEY 1000ML PUMP SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11414213
• Report Number: 1282497-2021-09951
• Device Sequence Number: 11756345
• Product Code: LZH
• UDI-Device Identifier: 10884521072305
• UDI-Public: 10884521072305
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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: 763656
• Device Catalogue Number: 763656
• Device Lot Number: 203140083
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/04/2021
• Supplement Report FDA Received Date: 04/23/2021
• Patient Sequence Number: 1