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

Model Number	763662
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2020
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 device cracked at the port causing the nutrition to leak.There was no patient injury.
Additional Manufacturer Narrative
A review of the device history record revealed no discrepancies that may have contributed to the reported condition.All quality assurance testing is performed during the manufacturing of the product met specification requirements.A photograph was submitted for evaluation, however based on the digital image it is not possible to confirm the reported condition.The physical sample is needed to assess the reported condition and thus determine the potential root cause.This complaint will be closed with no further action.If a sample is received, the complaint will be reopened for investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: JOEY 1000ML FEED/FLUSH SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10108999
• Report Number: 1282497-2020-09092
• Device Sequence Number: 16996112
• Product Code: LZH
• UDI-Device Identifier: 10884521072312
• UDI-Public: 10884521072312
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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: 763662
• Device Catalogue Number: 763662
• Device Lot Number: 200100092
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 08/18/2020
• Patient Sequence Number: 1