Catalog Number 123516A |
Device Problem
Burst Container or Vessel (1074)
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Patient Problem
Urinary Retention (2119)
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Event Date 08/13/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The reported event was inconclusive because no sample was returned.However, the potential root cause for this failure mode could be user related (example: contact with sharp object)/ exposure to petrolatum based products/ mechanical failure/ operator 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: "structure & composition: the product include three series: bardex, bardic and bardia.The composition of each series is as follows: bardex, bardic and bardia bi-lumen series are composed of catheter body, inflation cone interface, balloon and valve.Bardia tri-lumen is composed to tube body, inflation cone interface, deflation cone interface, flush cone interface, balloon and valve.¿the product is with silicone coating.The material of catheter body, inflation conical interface, deflation conical interface, flushing conical interface, balloon is natural latex.The material of valve is polypropylene.Sterilized by radiation.Disposable.Scope of application: foley catheter is intended for use in the drainage of urine from the bladder of children and adults.Precaution: this product contains natural rubber latex which may cause allergic reaction.Sterile unless package has been opened or damage.Warning: do not use petroleum substrate lubricants with the latex- based urethral catheters such as petroleum jelly and label liquid paraffin, which will damage latex and may burst balloon.Water-soluble lubricant can be used.Valve type: use luer slip syringe.Do not use needle.To deflate catheter balloon: gentle insert a syringe in the catheter valve.Never use excessive force to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen.If permitted by hospital practical, the valve may be cut off.If this fails, please contact an adequately trained professional for assistance, as directed by hospital practical.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Storage: catheters need to be stored at room temperature and keep away from the direct light and preferably stored in the original packing box.Do not use the product of have latex allergy." h11: section a through f - the information provided by bd represents all 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.H3 other text : the device was not returned.
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Event Description
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It was reported that at 11:00 on (b)(6) 2023, the patient was admitted to the hospital due to sudden left waist and abdominal pain without obvious inducement two days ago.The pain recurred and worsened in paroxysms.The pain was severe and accompanied by nausea and desire to vomit.There was no gross hematuria.After completing relevant examinations, the patient was diagnosed with left hydronephrosis, renal ureteral stones with infection, and right renal stones.At 13:45 on (b)(6) 2023, the patient underwent left transurethral ureteroscopy and pelvic laser lithotripsy, left ureteroscopy, left ureteral stent placement under general anesthesia.After the operation, the foley catheter was inspected.In good condition, according to the operating specifications, a foley catheter was inserted into the patient and the catheter was retained.At 14:50 on (b)(6) 2023, the ward was inspected.The patient complained that they had less urine in the urine bag.The user checked the urinary catheter and gently pulled the urinary catheter.The urinary catheter slipped out of the body.After checking the urinary catheter, it was found that the air bag had ruptured, which delayed the patients catheterization.Immediately, replace the sterile catheter with a new one and reinsert it.At 16 o'clock, the patient was inspected and the urinary catheterization was normal and the adverse events improved.
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Search Alerts/Recalls
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