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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN POLYUR F T 6.5FRX36IN W ENFIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
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COVIDIEN POLYUR F T 6.5FRX36IN W ENFIT; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS Back to Search Results
Model Number 461438E
Medical Device Problem Code Material Integrity Problem (2978)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/06/2020
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 they received the tube with a defective tip, it looked like it was cut across.
 
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Brand Name
POLYUR F T 6.5FRX36IN W ENFIT
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 Key10111933
Report Number9612030-2020-02484
Device Sequence Number3407907
Product Code PIF
UDI-Device Identifier10884521547148
UDI-Public10884521547148
Combination Product (Y/N)N
Initial Reporter StateAZ
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) 06/02/2020
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 Number461438E
Device Catalogue Number461438E
Device Lot Number1821903564
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/06/2020
Initial Report FDA Received Date06/02/2020
Patient Sequence Number1
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