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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® ALL-SILICONE TEMP SENSING FOLEY CATHETER

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C.R. BARD INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® ALL-SILICONE TEMP SENSING FOLEY CATHETER Back to Search Results
Model Number 119216M
Device Problem Material Puncture/Hole (1504)
Patient Problem Urinary Retention (2119)
Event Date 02/02/2023
Event Type  malfunction  
Event Description
It was reported that the urethral catheter was removed due to complaints of bladder retention.The bulb was deflated which had only 3 cc of a clear yellow color fluid.Catheter bulb was rechecked and re-inflated to rule out malfunction and it was noted that the bulb did have a leak.It was also stated that the patient was able to urinate on her own and was not recatheterized.No medical intervention was reported.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
 
Event Description
It was reported that the urethral catheter was removed due to complaints of bladder retention.The bulb was deflated which had only 3 cc of a clear yellow color fluid.Catheter bulb was rechecked and re-inflated to rule out malfunction and it was noted that the bulb did have a leak.It was also stated that the patient was able to urinate on her own and was not recatheterized.No medical intervention was reported.
 
Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "imperfection in balloon due to process".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The dhr review could not be performed without a lot number.The instructions for use were found adequate and state the following: "proper techniques for urinary catheter insertion; perform hand hygiene immediately before and after insertion; ¿ insert urinary catheters using aseptic technique and sterile equipment; use the smallest foley catheter possible, consistent with good drainage; document the indications for catheter insertion, date and time of catheter insertion, individual who inserted catheter, and date and time of catheter removal in patient record proper techniques for urinary catheter maintenance; secure the foley catheter, use the statlock® foley stabilization device if provided; maintain a closed drainage system by utilizing pre-connected, sealed catheter-tubing junctions; maintain unobstructed urine flow and keep the catheter and collection tube free from kinking; keep the collection bag below the level of the bladder or hips at all times; empty the collection bag regularly (e.G., prior to transport) using a separate, clean collection container for each patient; routine hygiene (e.G., cleansing of the meatal surface during daily bathing or showering) is appropriate; leave foley catheter in place only as long as needed.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Single use only.Do not resterilize.For urological use only.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause balloon to burst.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.Visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use." h11: section a through f - 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.H3 other text: the device was not returned.
 
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Brand Name
BARDEX® LUBRI-SIL® ALL-SILICONE TEMP SENSING 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
xeeroy rada
8195 industrial blvd
covington 30014
7707846100
MDR Report Key16582695
MDR Text Key312295387
Report Number1018233-2023-01905
Device Sequence Number1
Product Code EZL
UDI-Device Identifier00801741046308
UDI-Public(01)00801741046308
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070582
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number119216M
Device Catalogue Number119216M
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/20/2023
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
Patient Outcome(s) Other;
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