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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 SILICONE CHANNEL DRAIN WITHOUT TROCAR, 19 FR., ROUND HUBLESS, FULL FLUTED

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PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 SILICONE CHANNEL DRAIN WITHOUT TROCAR, 19 FR., ROUND HUBLESS, FULL FLUTED Back to Search Results
Catalog Number V072230
Device Problem Fitting Problem (2183)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was not returned.
 
Event Description
It was reported that the size of the channel drain was larger than devices previously used (072230), and would not fit on the bulb.The user stated there is a visible difference in diameter when the drains are next to each other.
 
Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use state the following: " drain placement and the fr size is indicated: reorder #: drain size: drain shape: fluting trocar depth indicator: v072230, 19 fr.Round hubless, full ¿, dot.V072234, 24 fr.Round hubless full ¿ dot." (b)(4).The device was not returned.
 
Event Description
It was reported that the size of the channel drain was larger than devices previously used (b)(4), and would not fit on the bulb.The user stated there was a visible difference in diameter when the drains were next to each other.
 
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Brand Name
SILICONE CHANNEL DRAIN WITHOUT TROCAR, 19 FR., ROUND HUBLESS, FULL FLUTED
Type of Device
CHANNEL DRAIN
Manufacturer (Section D)
PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
km. 7 carretera internacional
nogales, sonora 85621
MX  85621
Manufacturer (Section G)
PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
km. 7 carretera internacional
nogales, sonora 85621
MX   85621
Manufacturer Contact
amy gravley
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key6679850
MDR Text Key78904507
Report Number1018233-2017-03405
Device Sequence Number1
Product Code GBX
UDI-Device Identifier00801741051616
UDI-Public(01)00801741051616
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/12/2017
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
Device Operator Health Professional
Device Catalogue NumberV072230
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/09/2017
Initial Date FDA Received06/29/2017
Supplement Dates Manufacturer Received06/30/2017
Supplement Dates FDA Received07/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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