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C.R. BARD, INC. (COVINGTON) -1018233 PUREWICK URINE COLLECTION SYSTEM; PUREWICK ACCESSORIES REPLACEMENT KIT
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| Model Number PW100 |
| Device Problems
Fracture (1260); Suction Failure (4039)
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| Patient Problem
Urinary Tract Infection (2120)
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| Event Date 10/26/2020 |
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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.
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Event Description
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It was reported that the patient has experienced urinary tract infection from the pure wick urine collection system not suctioning up the urine and the patient was sitting in it.Also stated that the wick would not work well and it leaked.The patient received help from others, but still could not get it placed so that it would not leak.Hence, the patient was having urinary tract infection from the wick not suctioning and staying wet all the time.The canister kept cracking and it needs to be made of a softer plastic as it was too hard and cracked too easily, while taking the top off and putting it back on.It is unknown what medical intervention was provided for the urinary tract infection.
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Event Description
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It was reported that the patient has experienced urinary tract infection from the pure wick urine collection system not suctioning up the urine and the patient was sitting in it.Also stated that the wick would not work well and it leaked.The patient received help from others, but still could not get it placed so that it would not leak.Hence, the patient was having urinary tract infection from the wick not suctioning and staying wet all the time.The canister kept cracking and it needs to be made of a softer plastic as it was too hard and cracked too easily, while taking the top off and putting it back on.It is unknown what medical intervention was provided for the urinary tract infection.
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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 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.H3 other text : the device was not returned.
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Manufacturer Narrative
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The reported event was confirmed by capa association.Returned complaint sample evaluations were reviewed to understand broken canister failure modes in the field as there were no related incoming non-conformances.Returned samples evaluation confirmed canister breakage occurs shortly after use and exhibits the cracked rim failure mode (approx.86%).Cracked canister body was confirmed to be the out of box failure mode during sample evaluation (approx.5%).Subsequently, the investigation team used a fishbone tool to identify possible causes and unlikely possible causes were eliminated.Possible causes identified in the fishbone analysis were canister rim breaks during placement or removal of the lid, dropped during shipping (eliminated as a cause for rim breakage, only a cause for out of box canister body breaks based on sample evaluation and packaging engineering evaluation), canister strength may be compromised by incorrect cleaning and/or drying and material is inadequate for multiples uses connections (depending on placement and removal technique, failure can occur).Finally the 5 why tool was used on likely possible causes to help determine the following technical root cause for broken canister rim: lid and canister are not designed for regular removal (e.G.Features for removal are not intuitive or optimally designed) and lid can catch on canister rim during removal or placement.In addition, it is possible canister strength may be compromised by incorrect cleaning (i.E.Chemicals) and/or with high temperature drying (e.G.Dishwasher).The device history record review was not performed as the lot number was unknown and it was confirmed by association with a capa.The instructions for use were found adequate and state the following: "lift collection canister from purewick¿ urine collection system.Do not lift canister by the lid.Take canister into an area appropriate for disposal e.G.A bathroom, carefully remove the lid, and dispose of urine in a proper receptacle e.G.A toilet or according to facility protocol.Place the collection canister (c) in the pure wick¿ urine collection system base and press down firmly on the lid making sure the lid is sealed.Attach the pump tubing (d) to the pure wick¿ urine collection system connector port (f) and the connector port (e) on the collection canister lid.Attach the collector tubing (g) to the connector port (h) on the collection canister lid.Connect the other end of the collector tubing securely to a pure wick¿ external catheter (i).[note the letters correlate to a diagram within the ifu].Caution: it is important that the port connections be connected correctly and securely for proper operation of the purewick¿ urine collection system.It also states ¿replacing canister and tubing: replace the canister and tubing for each patient per facility protocol or at least every 60 days, whichever is sooner.If you notice any of the following, replace immediately: canister or tubing has residual urine build-up, canister or tubing appear cloudy, canister or tubing appear discolored, canister becomes cracked, tubing becomes torn, purewick¿ external catheter no longer securely connects to collector tubing failure to clean and/or replace accessories may affect the performance of the system.The useful life of the collection canister and tubing is 60 days.Precautions:do not use barrier cream on the perineum when using the purewicktm female external catheter.Barrier cream may impede suction.Ensure the purewicktm female external catheter remains in the correct position after turning the patient.Remove the purewicktm female external catheter prior to ambulation.Properly placing the purewicktm female external catheter snugly between the labia and gluteus holds the purewicktm female external catheter in place for most patients.Mesh underwear may be useful for securing the purewicktm female external catheter for some patients.Recommendations: assess device placement and patient¿s skin at least every 2 hours.Replace the purewicktm female external catheter every 8-12 hours or when soiled with feces or blood.Change suction tubing per hospital protocol or at least every thirty (30) days." 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.H3 other text : the device was not returned.
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Event Description
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It was reported that the patient has experienced urinary tract infection from the pure wick urine collection system which was not suctioning up the urine and the patient was sitting in it.It was also stated that the wick would not work well and it leaked.The patient received help from others, but still could not get it placed so that it would not leak.Hence, the patient was having urinary tract infection from the wick not suctioning and staying wet all the time.The canister kept cracking and it needs to be made of a softer plastic as it was too hard and cracked too easily, while taking the top off and putting it back on.It was unknown what medical intervention was provided for the urinary tract infection.
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