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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; FOLEY CATHETER (SILICONE)

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C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER; FOLEY CATHETER (SILICONE) Back to Search Results
Catalog Number 1758SI14
Device Problems Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Date 03/23/2020
Event Type  malfunction  
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 foreign material was found on the catheter when the package was opened.Per additional information received via email on april 3, 2020, the foreign material was found inside the catheter.
 
Manufacturer Narrative
The reported event was confirmed.The device had not met specifications.The product was intended to be used for treatment purposes.The product was influenced by the reported failure.Visual inspection noted foreign material inside the catheter.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be, ¿environmental, alcohol, operation error.¿ 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: [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, 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 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.
 
Event Description
It was reported that foreign material was found on the catheter when the package was opened.Per additional information received via email on april 3, 2020, the foreign material was found inside 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)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key9982720
MDR Text Key188893172
Report Number1018233-2020-02754
Device Sequence Number1
Product Code MJC
Combination Product (y/n)N
PMA/PMN Number
K984136
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 05/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/06/2024
Device Catalogue Number1758SI14
Device Lot NumberNGDP0403
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2020
Date Manufacturer Received05/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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