MAUDE Adverse Event Report: COVIDIEN JOEY 1000ML SAFETY SCREW SPIKE; PUMP, INFUSION, ENTERAL

Model Number	765100
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2020
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 device leaks from the base of the bag.There was no patient harm.
Additional Manufacturer Narrative
A review of the device history record shows evidence that the product was released according to all established procedures and qa documentation.Eighteen brand new devices were received for evaluation.A visual and functional inspection found no evidence of a leak in any of the devices.The root cause cannot be identified as the reported condition could not be confirmed based on the test results for the returned samples.A formal corrective/preventative action will not be initiated at this time as the reported condition did not identify a manufacturing or production process.This complaint will be closed with no further action and will be used for tracking and trending purposes.

• Brand Name: JOEY 1000ML SAFETY SCREW SPIKE
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10420506
• Report Number: 1282497-2020-09353
• Device Sequence Number: 2795210
• Product Code: LZH
• UDI-Device Identifier: 20884521155784
• UDI-Public: 20884521155784
• 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): 11/20/2020

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: 765100
• Device Catalogue Number: 765100
• Device Lot Number: 193290070
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 11/20/2020
• Patient Sequence Number: 1