MAUDE Adverse Event Report: COVIDIEN K 924 500 ML FEEDING BAG; PUMP, INFUSION

Model Number	772025
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/19/2020
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 there were 7 defective pump sets that leaked out from the bottom where the tube is attached to the bag.
Additional Manufacturer Narrative
H 3 evaluation summary: the device history record (dhr) review of the reported lot number shows evidence that the product was released according to all established procedures and quality documentation.Ten used samples were received at the manufacturing site for evaluation.Samples were evaluated and one sample has a cut in the bag causing leaking.No formal investigation action is being taken since the failure mode is not a trend.This complaint will be closed with no further action and will be used for tracking and trending purposes.

• Brand Name: K 924 500 ML FEEDING BAG
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA
• MDR Report Key: 9628940
• Report Number: 1282497-2020-08878
• Device Sequence Number: 19479870
• Product Code: FRN
• UDI-Device Identifier: 10884521000759
• UDI-Public: 10884521000759
• 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,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2020

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: 772025
• Device Catalogue Number: 772025
• Device Lot Number: 190460063
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 01/24/2020
• Supplement Report FDA Received Date: 04/06/2020
• Patient Sequence Number: 1