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Catalog Number 123516A |
Device Problems
Restricted Flow rate (1248); Inaccurate Flow Rate (1249)
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Patient Problem
Abdominal Distention (2601)
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Event Date 10/26/2023 |
Event Type
Injury
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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.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.
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Event Description
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It was reported that the patient had a 16fr.Foley catheter placed in the emergency department on (b)(6) 2023.On (b)(6) 2023, the urine output suddenly decreased during the night shift.Nurse tried lowering the urinary catheter for drainage but still had no urine.After notifying the nurse practitioner and physician, the physician immediately performed bedside bladder ultrasound., it was found that the patient had urinary distension.(the patient had a cervical spine injury.His limb muscle strength was 0 points, and they had no response to abnormal sensation and urinary distension.) therefore, the urinary catheter was removed immediately, but when the urinary catheter was removed, the balloon could not be drawn.The water came out, and after several attempts the water was successfully pumped out and the urinary catheter was removed.
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Event Description
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It was reported that the patient had a 16fr.Foley catheter placed in the emergency department on (b)(6) 2023.On (b)(6) 2023, the urine output suddenly decreased during the night shift.Nurse tried lowering the urinary catheter for drainage but still had no urine.After notifying the nurse practitioner and physician, the physician immediately performed bedside bladder ultrasound., it was found that the patient had urinary distension.(the patient had a cervical spine injury.His limb muscle strength was 0 points, and they had no response to abnormal sensation and urinary distension.) therefore, the urinary catheter was removed immediately, but when the urinary catheter was removed, the balloon could not be drawn.The water came out, and after several attempts the water was successfully pumped out and the urinary catheter was removed.
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Manufacturer Narrative
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The reported event was unconfirmed because the reported failure could not be reproduced.The product had not caused the reported failure.No root cause could be found because the reported event was unconfirmed.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: "sterile unless package is opened or damaged.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon burst.Do not aspirate urine through the drainage funnel wall.Single patient use only.Do not reuse and resterilize.For urological use only.Use luer slip syringe.Do not use needle.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required 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 protocol, the may be cut off.If this fails, contact an adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient." 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 actual/suspected device was inspected.
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Search Alerts/Recalls
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