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)
Date of Event	08/25/2021
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 that the feeding set was leaking at the tubing insertion area into the spike end.There was no patient harm reported.
Additional Manufacturer Narrative
Investigation conclusion: the report stated the feeding set was leaking at the tubing insertion area into the spike end.The reported product number 765100, joey cross spike feed & flush, with lot number 211020122 was investigated.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.Six (6) used products were returned for evaluation.Visual and functional testing performed confirmed the reported product failure of leak.The location of the leak was identified at the tubing and cross-spike connection.A formal investigation was initiated to determine the root cause of the confirmed product failure as well as actions necessary, if applicable, to prevent the confirmed product failure from recurring.This complaint will be used for monitoring 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
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12378637
• Report Number: 1282497-2021-10577
• Device Sequence Number: 19935239
• Product Code: LZH
• UDI-Device Identifier: 20884521155784
• UDI-Public: 20884521155784
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2021

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
• Device Model Number: 765100
• Device Catalogue Number: 765100
• Device Lot Number: 211020122
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/25/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 08/27/2021
• Supplement Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown