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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® ALL-SILICONE FOLEY CATHETER

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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® ALL-SILICONE FOLEY CATHETER Back to Search Results
Catalog Number 165820
Device Problems Burst Container or Vessel (1074); Deflation Problem (1149)
Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/27/2021
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported the balloon of the foley catheter was pierced in the urology department after installation in the operating room.The probe was available for a possible expertise per follow-up information received from ibc on 29oct2021, stated that the balloon was punctured remotely from the robotic radical prostatectomy procedure.The surgeon resuscitated the patient on duty.
 
Manufacturer Narrative
The reported event was inconclusive since the sample cannot be tested.1 sample was confirmed to exhibit the reported failure.It was unknown whether the device had met relevant specifications.The product was used for treatment.It was unknown whether the product had caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used two-way silicone foley catheter.Visual inspection of the sample noted the balloon was ruptured upon return.The inflation notch was inspected and found to be completely perforated.A potential root cause for this failure could be poor balloon design.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "to deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If necessary, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient." correction: h h11: section a through f - the information provided by bd represents all 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 bd.H3 other text : the actual/suspected device was inspected.
 
Event Description
It was reported the balloon of the foley catheter was pierced in the urology department after installation in the operating room.The probe was available for a possible expertise per follow-up information received from ibc on 29oct2021, stated that the balloon was punctured remotely from the robotic radical prostatectomy procedure.The surgeon resuscitated the patient on duty.Per follow-up information received on 16nov2021, it was stated that the there was no resuscitated patient.The surgeon did place another probe.The balloon was punctured and burst distantly from the robotic radical prostatectomy procedure.The surgeon on duty placed another probe in the patient.
 
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Brand Name
BARDEX® ALL-SILICONE FOLEY CATHETER
Type of Device
FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
Manufacturer Contact
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key12836283
MDR Text Key280956176
Report Number1018233-2021-07342
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K040504
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/28/2024
Device Catalogue Number165820
Device Lot NumberMYFR1874
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/27/2021
Initial Date FDA Received11/18/2021
Supplement Dates Manufacturer Received04/29/2022
Supplement Dates FDA Received05/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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