C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER; FOLEY CATHETER (SILICONE)
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Catalog Number 1758SI16 |
Device Problems
Break (1069); Fluid/Blood Leak (1250); Leak/Splash (1354)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 11/12/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.
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Event Description
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It was reported that a urine leak occurred some where on the catheter on the 8th day of use.Per additional information from the ibc via email 16 dec 2019, it was unknown where the urine leaked from.
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Manufacturer Narrative
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The reported event was confirmed, however, the cause is unknown.Visual evaluation noted the photo shows a two-way silicone foley catheter with a large hole in the drainage lumen.This is considered a failure per inspection procedure stating that cuts in lumens are not allowed.Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure could be inappropriate material handling (silicone catheters).The lot number is unknown; therefore, the device history record could not be reviewed.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 injuryed.] 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% povidine-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, contract 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.] directions for use: 1) clean the area around the external urethral meatus with the packaged cotton balls immersed in the antiseptics.2) lubricate the catheter shaft with the lubricant jelly.3) carefully insert the catheter into the urethral meatus.After the balloon advanced in the bladder, attach the needleless syringe, and gently infuse the specified volume of sterile water to inflate the balloon.4) pull the catheter slightly to seat the balloon at the level of the bladder neck.5) to deflate and remove the balloon, attach a needleless syringe to let sterile water in the balloon come out spontaneously through balloon deflation without aspiration.After balloon deflation, withdraw the catheter slowly while confirming that no abnormal resistance is encountered." 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.
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Event Description
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It was reported that a urine leak occurred some where on the catheter on the 8th day of use.Per additional information from the ibc via email 16dec2019, it was unknown where the urine leaked from.Per additional information from the ibc via email 06feb2020; the catheter was broken on the drainage funnel at the bifurcation.
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Event Description
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It was reported that a urine leak occurred some where on the catheter on the 8th day of use.Per additional information from the ibc via email 16dec2019, it was unknown where the urine leaked from.
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Manufacturer Narrative
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The reported event was inconclusive as no sample was returned for evaluation.A potential failure mode could be ¿leaks¿ with a potential root cause of ¿bad fit with shaft¿.The lot number is unknown; therefore, the device history record could not be reviewed.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 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% povidine-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, contract 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.] directions for use: 1) clean the area around the external urethral meatus with the packaged cotton balls immersed in the antiseptics.2) lubricate the catheter shaft with the lubricant jelly.3) carefully insert the catheter into the urethral meatus.After the balloon advanced in the bladder, attach the needleless syringe, and gently infuse the specified volume of sterile water to inflate the balloon.4) pull the catheter slightly to seat the balloon at the level of the bladder neck.5) to deflate and remove the balloon, attach a needleless syringe to let sterile water in the balloon come out spontaneously through balloon deflation without aspiration.After balloon deflation, withdraw the catheter slowly while confirming that no abnormal resistance is encountered." 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.
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