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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 2-WAY 5CC ALL-SILICONE FOLEY CATHETER, TWO OPPOSED EYES
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PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARDEX 2-WAY 5CC ALL-SILICONE FOLEY CATHETER, TWO OPPOSED EYES Back to Search Results
Catalog Number 165818
Device Problems Hole In Material (1293); Device Dislodged or Dislocated (2923)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/11/2016
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 the catheter was dislodged.One day after the insertion of the catheter, the dislodgement was found.It was later confirmed by medicon that there was a pinhole in the balloon.
 
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 the catheter was dislodged.One day after the insertion of the catheter, the dislodgement was found.It was later confirmed by medicon that there was a pinhole in the balloon.
 
Manufacturer Narrative
Received 1 used silicone catheter.The sample was visually inspected and no damages along the catheter were found.Per the functional evaluation, the balloon was inflated with 10cc of air using a syringe, and then deflated.After the balloon was inflated with 10 cc of a mix of tap water and blue methylene using a syringe, the water immediately came out due to a balloon pinhole.The sample was observed under 10 x magnification and no embedded particles were found in the balloon area.Per the dimensional evaluation, the balloon's active length was measured to be 0.8435¿ on one side and 0.8470¿ on the other side (specification indicates 0.6 - 0.9 in.).The balloon active length was found to be within specifications.The reported event was confirmed with an unknown cause.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "recommended inflation capacities: 3cc balloon: use 5ml sterile water, 5cc balloon: use 10ml sterile water, 30cc balloon: use 35ml sterile water.Do not exceed recommended capacities.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol." (b)(4).
 
Event Description
It was reported that the catheter was dislodged.One day after the insertion of the catheter, the dislodgement was found.It was later confirmed by medicon that there was a pinhole in the balloon.
 
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Brand Name
BARDEX 2-WAY 5CC ALL-SILICONE FOLEY CATHETER, TWO OPPOSED EYES
Type of Device
FOLEY CATHETER
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 Key6072615
MDR Text Key59292782
Report Number1018233-2016-01533
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
PMA/PMN Number
K040504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Reporter Occupation Nurse
Type of Report Initial,Followup,Followup
Report Date 11/21/2016
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 Expiration Date03/31/2021
Device Catalogue Number165818
Device Lot NumberNGAQ3644
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/12/2016
Initial Date FDA Received11/02/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received11/21/2016
12/02/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/11/2016
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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