MAUDE Adverse Event Report: COVIDIEN JOEY 500ML PUMP SET; PUMP, INFUSION, ENTERAL

Model Number	762055
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2020
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 the bags are leaking.There was no patient harm.
Additional Manufacturer Narrative
Additional information: h2, h3, h4, h6 investigation summary: the customer reported the bags leaked.No patient injury/harm was reported.A device history record 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 trending was reviewed and no trend was identified for the reported lot number or device failure.A total of twelve (12) unused samples were returned for evaluation.Visual inspection and functional testing performed confirmed the reported failure of leak between the bag and the bushing tube.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.Investigation.

• Brand Name: JOEY 500ML PUMP SET
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10810412
• Report Number: 1282497-2020-09613
• Device Sequence Number: 3799593
• Product Code: LZH
• UDI-Device Identifier: 10884521072299
• UDI-Public: 10884521072299
• 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
• Report Date (Section B): 03/02/2021

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: 762055
• Device Catalogue Number: 762055
• Device Lot Number: 201460041
• Initial Date Received by Manufacturer: 10/29/2020
• Supplement Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 03/02/2021
• Patient Sequence Number: 1