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Device Problem
Material Invagination (1336)
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Patient Problems
Pain (1994); Skin Discoloration (2074); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 09/12/2022 |
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.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 urinary catheters were not properly deflating upon removal which caused injury, pain or need for urology involvement.The nursing staff were educated on making sure they were passively deflating the bulb before removal.Stated that the two incidences that week the nurse followed that process.When looked at the catheter after removal there was a small ridge that has formed and when tested the balloon after removal, it was difficult to inflate, the balloon inflated only on one side and then finally with pressure inflated the full balloon.
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Manufacturer Narrative
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The reported event was inconclusive due to sample received condition, which we were unable to perform test.It is unknown whether the device had met relevant specifications.The product was used for patient treatment or diagnosis.It was unknown whether the product had caused the reported failure.A potential root cause for this failure mode could be balloon material does not shrink quickly enough.Visual evaluation of the returned sample noted one opened (without original packaging),1 foley catheter.Visual inspection noted that the inflation arm and funnel were cut off.Due to the inflation arm and funnel being cut off, it is not possible to inflate the sample as the size of the syringe head itself is bigger than the shaft of the catheter.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: the product catalog number for this device is unknown.Therefore, bd is unable to determine the associated labeling to review.The actual/suspected device was inspected.
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Event Description
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It was reported that the urinary catheters were not properly deflating upon removal which caused injury, pain or need for urology involvement.The nursing staff were educated on making sure they were passively deflating the bulb before removal.Stated that the two incidences that week the nurse followed that process.When looked at the catheter after removal there was a small ridge that has formed and when tested the balloon after removal, it was difficult to inflate, the balloon inflated only on one side and then finally with pressure inflated the full balloon.Per follow up response received via email on 05-oct-2022, stated that the patient's foley order was discontinued.The foley catheter's balloon was documented as being filled with 5 ml.The nurse deflated the balloon, only refracting approximately four mls.Registered nurse tried two more times to deflate the balloon but only extracted air.Registered nurse the began to remove the foley catheter from patient's urethra and no resistance was met until the tip of the catheter met the tip of the patient's penis.The resistance was not resolved with gentle tugging.It appeared that the foley was stuck in the penis.The registered nurse called one the procedure nurses who then brought in the nurse practitioner.Nurse practitioner applied more force after examining the situation and penis and the foley came out.Stated that upon examination, the foley catheter's deflated balloon had made a wrinkle around the foley which had been the reason the foley met resistance at the end of the penis.The nurse practitioner inflated the balloon of the foley, then out of the patient and all three healthcare professionals saw that the balloon did not inflate equally around the tube, leading all three to wonder if the defect in the product caused more trauma than necessary to the patient's urethra.Urethra was more red than normal after removal.
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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 urinary catheters were not properly deflating upon removal which caused injury, pain or need for urology involvement.The nursing staff were educated on making sure they were passively deflating the bulb before removal.Stated that the two incidences that week the nurse followed that process.When looked at the catheter after removal there was a small ridge that has formed and when tested the balloon after removal, it was difficult to inflate, the balloon inflated only on one side and then finally with pressure inflated the full balloon.Per follow up response received via email on 05-oct-2022, stated that the patient's foley order was discontinued.The foley catheter's balloon was documented as being filled with 5 ml.The nurse deflated the balloon, only refracting approximately four mls.Registered nurse tried two more times to deflate the balloon but only extracted air.Registered nurse the began to remove the foley catheter from patient's urethra and no resistance was met until the tip of the catheter met the tip of the patient's penis.The resistance was not resolved with gentle tugging.It appeared that the foley was stuck in the penis.The registered nurse called one the procedure nurses who then brought in the nurse practitioner.Nurse practitioner applied more force after examining the situation and penis and the foley came out.Stated that upon examination, the foley catheter's deflated balloon had made a wrinkle around the foley which had been the reason the foley met resistance at the end of the penis.The nurse practitioner inflated the balloon of the foley, then out of the patient and all three healthcare professionals saw that the balloon did not inflate equally around the tube, leading all three to wonder if the defect in the product caused more trauma than necessary to the patient's urethra.Urethra was more red than normal after removal.
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Search Alerts/Recalls
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