C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. FOLEY CATHETER; FOLEY CATHETER (LATEX)
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Model Number 0165SI18 |
Device Problems
Deflation Problem (1149); Inaccurate Flow Rate (1249); No Flow (2991)
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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 10/25/2018 |
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 it was difficult to deflate the balloon of the catheter on the day of placement.The user cut the shaft and tried to deflate the balloon by pumping, but only 2-3 ml of water came out.The user inserted a guidewire into the inflation lumen, but no water came out.Finally, the balloon was punctured percutaneously, and the catheter was removed.It was later reported that there was no urine flow after the catheter was placed.Allegedly, this is why the user decided to replace the catheter.
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Event Description
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It was reported that it was difficult to deflate the balloon of the catheter on the day of placement.The user cut the shaft and tried to deflate the balloon by pumping, but only 2-3 ml of water came out.The user inserted a guidewire into the inflation lumen, but no water came out.Finally, the balloon was punctured percutaneously, and the catheter was removed.It was later reported that there was no urine flow after the catheter was placed.Allegedly, this is why the user decided to replace the catheter.
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Manufacturer Narrative
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The reported event was inconclusive due to poor sample condition.Received only catheter cut into 3 pieces at the inflation funnel and also bifurcation area.The sample was evaluated and a balloon burst was observed, as the user had percutaneously punctured the balloon to remove the catheter from the user.The evaluation found no pinch or blockage on the returned catheter as water could be introduced into the lumen by using a needle syringe.However, a complete evaluation could not be performed due to the poor condition of the returned sample.The potential root cause for this failure mode could be user related (example: over aspirated, incorrect syringe)/collapse lumen/sac close eye/valve damage.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 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 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 (1) who are or have been allergic to natural rubber latex (2) with known allergy to silver coated catheter".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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