Model Number MECRR030 |
Device Problem
Incomplete or Missing Packaging (2312)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/27/2022 |
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.
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Event Description
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It was reported that the customer had come across a product labeling error with surestep male external catheter.Customer stated that the plastic round piece was supposed to be labeled 1 however they were labeled 2 instead.Customer has 2 full cases of lot# jugs9085 with the incorrect number and also lot# jugs0436 and lot# jugs9259.They thought this was not a defective issue but believed manufacturing had a shortage in the white plastic holder for the new condom catheters.It looked like they used ones with an internal labeling of ¿2¿ instead of ¿1¿ because of a shortage in packaging parts.Customer was using this small number as a means of sizing even though it was not listed on the dfu (directions for use).
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Manufacturer Narrative
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The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "operator error".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review is not required because a review of the label could not have prevented the reported failure.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 had come across a product labeling error with surestep male external catheter.Customer stated that the plastic round piece was supposed to be labeled 1 however they were labeled 2 instead.Customer has 2 full cases of lot# jugs9085 with the incorrect number and also lot# jugs0436 and lot# jugs9259.They thought this was not a defective issue but believed manufacturing had a shortage in the white plastic holder for the new condom catheters.It looked like they used ones with an internal labeling of ¿2¿ instead of ¿1¿ because of a shortage in packaging parts.Customer was using this small number as a means of sizing even though it was not listed on the dfu (directions for use).
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Search Alerts/Recalls
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