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 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 the feeding sets are leaking.There was no patient harm.
Additional Manufacturer Narrative
The device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.Two samples were received for evaluation.A visual and functional inspection was conducted and determined that a detached cross spike from the line caused the product to leak.As part of continuous improvements, a formal investigation has been opened to determine the root cause and implement the appropriate corrective actions to prevent the recurrence of the reported issue.This complaint will be used for qa 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: 11932130
• Report Number: 1282497-2021-10235
• Device Sequence Number: 3181965
• 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): 10/01/2021

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?: No
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 10/01/2021
• Patient Sequence Number: 1