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 Clinical Signs, Symptoms or Conditions (4582)
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 been having issues with the feeding sets leaking.
Additional Manufacturer Narrative
Investigation summary: the customer reported having issues with the feeding sets leaking.The customer stated three (3) have been opened with issues and they still have fifteen (15) unused that they do not want to try.No patient harm/injury was reported.The report refers to product code 765100, joey cross spike feed & flush, with lot number 200410167.The 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.Lot and failure mode trending was reviewed and no relating trends were identified over a 2-year period.A total of fifteen (15) unused samples were received for evaluation.Visual inspection and functional testing performed confirmed the report of leak between the cross-spike and tubing line.An investigation has been initiated to determine the root cause of this confirmed device failure.No further escalation/action is required at this time.This complaint 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: 11330467
• Report Number: 1282497-2021-09913
• Device Sequence Number: 1112597
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2021

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: 765100
• Device Catalogue Number: 765100
• Device Lot Number: 200410167
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 02/12/2021; 02/12/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 02/23/2021; 05/11/2021
• Patient Sequence Number: 1