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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 2 SHORT SHEATH; MALE EXTERNAL CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 ROCHESTER MEC SPIRIT SHEATH STYLE 2 SHORT SHEATH; MALE EXTERNAL CATHETER Back to Search Results
Model Number 37301
Medical Device Problem Code Nonstandard Device (1420)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the male external catheter ifus are found to be adequate based on past reviews.The device was not returned.
 
Event or Problem Description
It was reported that the cathether had too much adhesive.The patient advised that the adhesive made it uncomfortable to use the catheters.No medical intervention was reported.
 
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Brand Name
ROCHESTER MEC SPIRIT SHEATH STYLE 2 SHORT SHEATH
Common Device Name
MALE EXTERNAL CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8624359
Report Number1018233-2019-02623
Device Sequence Number2169075
Product Code NNX
UDI-Device Identifier00801741071171
UDI-Public(01)00801741071171
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer,distributor,other
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 05/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Operator of Device Lay User/Patient
Device Model Number37301
Device Catalogue Number37301
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/29/2019
Initial Report FDA Received Date05/20/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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