MAUDE Adverse Event Report: COVIDIEN KANG EPUMP 1000ML PUMP ST-INTL; PUMP, INFUSION, ENTERAL

Model Number	673656
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
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that when the nurse started the feeding, the feeding bag started to leak in between the tubing that directly connected to the feeding bag.No patient injury reported.
Additional Manufacturer Narrative
Investigation conclusion the customer reported when the nurse started the feeding, the feeding bag started to leak in between the tubing that directly connected to the feeding bag.No patient injury/harm was reported.This report refers to product code 673656, epump int.1000ml feed only ns, with lot number 210320033, manufactured on 13-feb-2021.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 no related trends were identified.The customer provided a video of the reported failure.Examination of the video confirmed the report of leak.One (1) used device was returned for evaluation.Visual inspection and functional testing performed confirmed the reported device failure of leak.A correction has been initiated and completed to replace the rf sealing machine.Additional action will not be taken at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: KANG EPUMP 1000ML PUMP ST-INTL
• Common Device Name: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11816499
• Report Number: 1282497-2021-10180
• Device Sequence Number: 14258832
• Product Code: LZH
• UDI-Device Identifier: 10884521028166
• UDI-Public: 10884521028166
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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
• Report Date (Section B): 08/09/2021

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: 673656
• Device Catalogue Number: 673656
• Device Lot Number: 210320033
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 08/09/2021
• Patient Sequence Number: 1