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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRI-SIL I.C. ALL-SILICONE FOLEY CATHETER
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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRI-SIL I.C. ALL-SILICONE FOLEY CATHETER Back to Search Results
Catalog Number 1758SI16
Device Problems Deflation Problem (1149); Fluid/Blood Leak (1250)
Patient Problems No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 11/02/2020
Event Type  Injury  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that the 16fr surestep foley balloon was not staying inflated after positioning.Both were discovered in the operating room while patient having c-section.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11:section a through f - the information provided by bd 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 bd.
 
Event Description
It was reported that the 16fr surestep foley balloon was not staying inflated after positioning.Both were discovered in the operating room (or) while patient having c-section.Per follow up via phone on 02dec2020, stated that one catheter was exploded, and another catheter was leaking, and stated that the balloons were inflated with the syringe included in the insertion kit.
 
Event Description
It was reported that the 16fr surestep foley balloon was not staying inflated after positioning.Both were discovered in the operating room (or) while patient having c-section.Per follow up via phone on 02dec2020, stated that one catheter was exploded, and another catheter was leaking, and stated that the balloons were inflated with the syringe included in the insertion kit.
 
Manufacturer Narrative
The reported event was unconfirmed since the problem could not be reproduced.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone foley catheter.Visual inspection of the sample noted no obvious visible defects.The catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and was allowed to rest for 30 minutes with no observed leaks.The catheter was passively deflated with no issues.The drainage lumen was flushed with no observed leaks.This meet specification per inspection procedure as "cuts in lumens are not allowed".No root cause could be found because the reported event was unconfirmed.The device history record review was not required as the reported event was unconfirmed.The instructions for use were found adequate and state the following: "[warnings] 1.Method for use (1) do not inflate the balloon in the urethra.[the urethra may be injured.] (2) do not pull the catheter hard.[the bladder/urethra may be injured.] 2.Applicable patients ·patients with delirium who might pull out catheter [when patient tugs at catheter unconsciously, the bladder and urethra may be damaged.] [contraindications] 1.Method for use: (1) do not reuse.(2) do not resterilize.(3) this device contains 10% povidone-iodine.For patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants.(4) be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (5) do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.] 2.Applicable patients with known allergy to silver coated catheter." h11:section a through f - the information provided by bd 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 bd.H3 other text : the actual/suspected device was inspected.
 
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Brand Name
BARDEX LUBRI-SIL I.C. ALL-SILICONE FOLEY CATHETER
Type of Device
FOLEY CATHETER
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington 30014
MDR Report Key10908818
MDR Text Key218690036
Report Number1018233-2020-21196
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 health professional,other
Type of Report Initial,Followup,Followup
Report Date 03/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/26/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1758SI16
Device Lot NumberNGET1965
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2020
Date Manufacturer Received03/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
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