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); Deflation Problem (1149); Fluid/Blood Leak (1250)
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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 11/26/2019 |
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.
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Event Description
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It was reported that water leakage occurred from the shaft of the catheter.
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Manufacturer Narrative
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The reported event was unconfirmed.Visual inspection noted one two-way silicone catheter received.Visual evaluation of the sample noted no obvious defects.The catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and the balloon concentricity was observed to be 50:50.The balloon rested for 30 minutes without leaks and passively deflated without issue or cuffing, returning 10ml of solution.The active length of the catheter balloon was measured (0.6945") and found to be within specification (0.60" - 0.90").The catheter measured to be 16 fr.The product was used for treatment purposes.It was determined that the product had no relationship to the event due to the investigation being unconfirmed through sample evaluation.The product met specifications."(1)do not reuse.(2)do not resterilize.(3)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.] (4)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: (1)patients who are or have been allergic to natural rubber latex (2)patients with known allergy to silver-containing 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.
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Event Description
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It was reported that water leakage occurred from the shaft of the catheter.
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Manufacturer Narrative
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The reported event was confirmed.Visual inspection noted one two-way silicone catheter was received.Visual evaluation of the sample noted no obvious defects.The catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and balloon concentricity was observed to be 50:50.The balloon rested for 30 minutes without leaks and passively deflated without issue or cuffing, returning 10ml of solution.The drainage lumen was flushed, and there was a hole measuring 0.0565" found located 1.0115" from the bifurcation.This is considered a failure per inspection procedure which states that cuts in lumens are not allowed.The active length of the catheter balloon was measured (0.6945") and found to be within specification (0.60" - 0.90").The catheter measured to be 16 fr.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 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: "(1)do not reuse.(2)do not resterilize.(3)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.] (4)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 (1)patients who are or have been allergic to natural rubber latex (2)patients with known allergy to silver-containing 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.
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Event Description
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It was reported that water leakage occurred from the shaft of the catheter.
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Search Alerts/Recalls
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