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)
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 feeding sets were leaking where the tube meets the connector.There was no harm to the patient.
Additional Manufacturer Narrative
Investigation results: 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.To date, samples have not been received for evaluation, however, photographs were provided via email.Examining the photographs provided confirmed the reported product issue of leak between the tubing and cross-spike connection.An investigation has been initiated to determine the root cause of this confirmed product failure as it relates to a manufacturing/production process issue.This product failure will continue to be monitored and trended.
Additional Manufacturer Narrative
Investigation summary: the customer reported the feeding sets were leaking where the tube meets the connector.No patient injury/harm was reported.A 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 not related trends identified.A photograph was provided by the customer.Visual inspection confirmed the report for leak where the tubing and cross-spike join.Eight (8) new samples were received for evaluation.Visual inspection and functional testing found six of the eight devices detached at the tubing and cross-spike connection.An investigation has been initiated to determine the root cause of the reported detachment/leak as it related to the manufacturing process.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: 10842704
• Report Number: 1282497-2020-09629
• Device Sequence Number: 14360009
• 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,Followup
• Report Date (Section B): 05/26/2021

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: 193290069
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 11/02/2020; 11/02/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 03/11/2021; 05/26/2021
• Patient Sequence Number: 1