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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN KANG EPUMP 1000ML PUMP ST-INTL; PUMP, INFUSION, ENTERAL
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COVIDIEN KANG EPUMP 1000ML PUMP ST-INTL; PUMP, INFUSION, ENTERAL Back to Search Results
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
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 the bag was torn by the membrane, when the feeding process was carried out.Additional information received from the customer stated that the bag was leaking.There was no patient harm reported.
 
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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 Key10972229
Report Number1282497-2020-09768
Device Sequence Number14526774
Product Code LZH
UDI-Device Identifier10884521028166
UDI-Public10884521028166
Combination Product (Y/N)N
Initial Reporter CountryCO
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 12/08/2020
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 Number673656
Device Catalogue Number673656
Device Lot Number162180277
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/25/2020
Initial Report FDA Received Date12/08/2020
Patient Sequence Number1
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