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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN 16FR SALEM W/ GIENTRI PORT WIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
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COVIDIEN 16FR SALEM W/ GIENTRI PORT WIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS Back to Search Results
Model Number 7771610E
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/19/2020
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 the tip of the drain broke off when the drain was straightened out by provider from packaging.
 
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Brand Name
16FR SALEM W/ GIENTRI PORT WIT
Common Device Name
GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
Manufacturer (Section D)
COVIDIEN
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX  22500
MDR Report Key10227335
Report Number9612030-2020-02518
Device Sequence Number13587256
Product Code PIF
UDI-Device Identifier10884521582736
UDI-Public10884521582736
Combination Product (Y/N)N
Initial Reporter StateWI
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/02/2020
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 Number7771610E
Device Catalogue Number7771610E
Device Lot Number2004400264
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/24/2020
Initial Report FDA Received Date07/02/2020
Patient Sequence Number1
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