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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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 as no sample was returned for evaluation.A potential root cause for this failure could be due to "operator error".The lot number was invalid; therefore, the device history record could not be reviewed.A labeling review was not required because labeling could not have prevented the reported issue.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.H3 other text : the device was not returned.
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Search Alerts/Recalls
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