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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER; FOLEY CATHETER (SILICONE)

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PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER; FOLEY CATHETER (SILICONE) Back to Search Results
Catalog Number 1758SI14
Device Problem No Flow (2991)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/12/2017
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.
 
Event Description
It was reported that water could not be injected into the balloon of the catheter.
 
Manufacturer Narrative
Upon further review, bard medical has determined that this mdr was initially reported in error on a 3500a form.The reported event was found to be exempt from reporting, per exemption e1998006.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.
 
Event Description
It was reported that water could not be injected into the balloon of the catheter.
 
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Brand Name
BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
Type of Device
FOLEY CATHETER (SILICONE)
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 Key6632605
MDR Text Key77416628
Report Number1018233-2017-03052
Device Sequence Number1
Product Code MJC
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K984136
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/24/2017
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 Number1758SI14
Device Lot NumberNGZJ3997
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/22/2017
Initial Date FDA Received06/09/2017
Supplement Dates Manufacturer Received07/24/2017
Supplement Dates FDA Received07/24/2017
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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