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

Model Number	673656
Medical Device Problem Code	Air/Gas in Device (4062)
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 the inside the tube contained a large amount of air bubbles during the feeding.No patient injury or adverse events were reported.
Additional Manufacturer Narrative
Investigation conclusion: the customer reported the inside the tube contained a large amount of air bubbles during the feeding.No patient injury or adverse events were reported.This report refers to product code 673656, epump int.1000ml feed only ns, with lot number 202370343, manufactured on 04-sep-2020.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.A photograph was provided by the customer.Examination of the photograph confirms the report of air in line with pump set.One (1) used device was returned for evaluation.Visual inspection and functional testing performed confirmed the report of air in line with pump set.An investigation has been initiated to determine the root cause of the confirmed device failure related to the manufacturing/production process.No further action will 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: 11750264
• Report Number: 1282497-2021-10136
• Device Sequence Number: 4357006
• 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: 202370343
• 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: 04/29/2021
• Supplement Report FDA Received Date: 08/09/2021
• Patient Sequence Number: 1
• Patient Age: 21 YR