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Catalog Number EPX1272/118BJP |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/09/2018 |
Event Type
malfunction
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Manufacturer Narrative
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This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).Brand name, unique identifier and protocol number 510k are unknown.No information has been provided to date.A device history record (dhr) review was not performed as the lot number was not available.A product sample was received for evaluation.Visual and functional testing were performed.As a result of observation under a microscope, it was confirmed that there was no portion on the tip side of the third hole, and that breakage occurred in the third hole.The customer's reported problem was confirmed.The root cause of the reported complaint was due to usage of the customer.No actions were taken for the primary concern reported.
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Event Description
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It was reported that during the use of the product, the customer noticed the epidural catheter was torn off.No patient injury was reported.
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Manufacturer Narrative
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Other, other text: no same or similar product was sold in the us, it was sold only in japan., corrected data: please disregard the initial report submitted with the mfr number: 3012307300-2022-26126.The report was submitted in error.
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Search Alerts/Recalls
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