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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN EPUMP 1000ML SAFETY SCREW SPIK; PUMP, INFUSION, ENTERAL

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COVIDIEN EPUMP 1000ML SAFETY SCREW SPIK; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 775100
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/11/2019
Event Type  malfunction  
Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
 
Event Description
The customer reported that the tubing leaked near the spike connector during set up.
 
Manufacturer Narrative
A review of the device history record could not be conducted because a lot number was not provided.A sample was not returned to the manufacturing site for evaluation however a photograph was submitted with the complaint report.An examination of the photograph demonstrates that a leak was detected near the cross spike the root cause and corrective/preventative actions (capa) for the reported condition is confirmed to be related to a manufacturing/production process.A formal capa has been issued and is currently in process.This complaint will be closed with no further action.If sample is received later, the complaint will be reopened for investigation.This complaint will be used for tracking and trending purposes.
 
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Brand Name
EPUMP 1000ML SAFETY SCREW SPIK
Type of Device
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA 02048
MDR Report Key9527418
MDR Text Key173035397
Report Number1282497-2019-08843
Device Sequence Number1
Product Code LZH
UDI-Device Identifier10884521155817
UDI-Public10884521155817
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 03/30/2020
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
Device Operator No Information
Device Model Number775100
Device Catalogue Number775100
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/11/2019
Initial Date FDA Received12/27/2019
Supplement Dates Manufacturer Received12/11/2019
Supplement Dates FDA Received03/30/2020
Patient Sequence Number1
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