Catalog Number 0165L14 |
Device Problems
Decrease in Pressure (1490); Material Rupture (1546); Device Fell (4014)
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Patient Problems
Pain (1994); No Consequences Or Impact To Patient (2199)
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Event Date 03/26/2020 |
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.The device was not returned.
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Event Description
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It was reported that the catheter balloon had burst three times on different days.It was also stated that most recently on (b)(6) 2020 the patient got pain with no pattern as to when it occurred and had a tremendous desire to pass urine and felt like the catheter exploded.It was also reported that the catheter fell out of the patient and on check of the catheter balloon burst was found.On (b)(6) 2020, the catheter fell out with severe pain to the patient.On (b)(6) 2020, the catheter fell out with balloon deflated.Catheter with lot number ngdz0222 inserted on (b)(6) 2020 was blocked.Catheter with lot number ngdz0222 inserted on (b)(6) 2020 had balloon burst with no visible encrustation.It was also stated that there had been other changes for bypassing but no records of encrustation in notes.When checked the paper record on site 3 of the 4 changes of catheter were ngdz0222 exp 3/12/22.There was no issue with storage of catheters.
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Manufacturer Narrative
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The reported event was inconclusive.No sample was returned for evaluation.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 lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "warning: do not use ointments or lubricants having a petrolatum base.They will damage latex.Visually inspect the product for any imperfections or surface deterioration prior to use.Use luer tip syringe to inflate with stated ml of sterile water.Or for pre-filled products, remove clip and squeeze reservoir to inflate with stated ml of sterile water." 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 the catheter balloon had burst three times on different days and stated that most recently on (b)(6) 2020 the patient got pain with no pattern as to when it occurred and had a tremendous desire to pass urine and felt like the catheter exploded.It was also reported that the catheter fell out of the patient and on check of the catheter balloon burst was found.On (b)(6) 2020, the catheter fell out with severe pain to the patient.On (b)(6) 2020, the catheter fell out with balloon deflated.Catheter with lot number ngdz0222 inserted on (b)(6) 2020 was blocked.Catheter with lot number ngdz0222 inserted on (b)(6) 2020 had balloon burst with no visible encrustation.There have been other changes for bypassing but no records of encrustation in notes.When checked the paper record on site 3 of the 4 changes of catheter were ngdz0222.I could not see any issue with storage of catheters at the property.
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Search Alerts/Recalls
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