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Catalog Number 0165SI18 |
Device Problem
Dent in Material (2526)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/10/2023 |
Event Type
malfunction
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Event Description
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It was reported that the customer was having issues with out catheters 3 of the lot (nghq2120), one of the lot (nggx2697) and other one of the lot (nggy1118) patient was trying to use catheter and the balloons were not inflating.The balloon on the item was not inflating correctly when in use, patient had no harm.
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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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Manufacturer Narrative
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The reported event was inconclusive because of poor sample condition.The potential root cause for this failure mode could be user related (example: under-inflation during use)/ assembly of the balloon to the shaft/ uneven thickness of balloon.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: "insert foley catheters only for appropriate indications and leave in place only as long as needed.Cdc guidelines for appropriate indications for indwelling urethral catheter use: patient has acute urinary retention or bladder outlet obstruction.Need for accurate urine output measurements.Use for selected surgical procedures.To assist in healing of open sacral or perineal wounds.Patient requires prolonged immobilization.To improve comfort for end of life care.Proper techniques for urinary catheter insertion: perform hand hygiene immediately before and after insertion.Insert urinary catheters using aseptic technique and sterile equipment.Use the smallest foley catheter possible, consistent with good drainage.Document the indications for catheter insertion, date and time of catheter insertion, individual who inserted catheter, and date and time of catheter removal in the patient record.Proper techniques for urinary catheter maintenance: secure the foley catheter.Use the statlock® foley stabilization device if provided maintain a closed drainage system by utilizing pre-connected, sealed catheter-tubing junctions maintain unobstructed urine flow and keep the catheter and collection tube free from kinking keep the collection bag below the level of the bladder or hips at all times empty the collection bag regularly using a separate, clean collection container for each patient generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder.However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as nephrostomy tract." h11: section a through f - the information provided by bard 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 bard.
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Event Description
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It was reported that the customer was having issues with 3 catheters of the lot (nghq2120), one of the lot (nggx2697) and other one of the lot (nggy1118) patient was trying to use catheter and the balloons were not inflating.The balloon on the item was not inflating correctly when in use, patient had no harm.
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Search Alerts/Recalls
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