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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LUKI ASP TUBES 61/4; CATHETER (GASTRIC, COLONIC, ETC.), IRRIGATION AND ASPIRATION
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COVIDIEN LUKI ASP TUBES 61/4; CATHETER (GASTRIC, COLONIC, ETC.), IRRIGATION AND ASPIRATION Back to Search Results
Model Number 8886864604
Medical Device Problem Codes Crack (1135); Degraded (1153)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 08/15/2019
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 device had a extremely dry tubing that was cracking.
 
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Brand Name
LUKI ASP TUBES 61/4
Common Device Name
CATHETER (GASTRIC, COLONIC, ETC.), IRRIGATION AND ASPIRATION
Manufacturer (Section D)
COVIDIEN
15 hampshire street
mansfield MA 02048
MDR Report Key8910902
Report Number1282497-2019-08612
Device Sequence Number2267537
Product Code KDH
UDI-Device Identifier30884527000108
UDI-Public30884527000108
Combination Product (Y/N)N
Initial Reporter StateDE
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/20/2019
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 Number8886864604
Device Catalogue Number8886864604
Device Lot Number182110004
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/15/2019
Initial Report FDA Received Date08/20/2019
Patient Sequence Number1
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