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Model Number 910100 |
Device Problem
Crack (1135)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/04/2022 |
Event Type
malfunction
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Event Description
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Surgiphor bottles busted during 2 total hip replacements.Customer response.Where on the bottle was the break, i.E., the cap, or the bottle (container)? if the bottle, was it at the seam? one bottle, one cap area (hole too large, caused leak).Please provide material/lot number ¿ if available? n/a.What was the effect on the patient if any? no effect.Was there a significant procedural delay? no.What was done to complete the irrigation process? continued use.
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Manufacturer Narrative
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Pro codes: fqh (lavage, jet) and fro (dressing, wound, drug).A photo was provided to our quality team for evaluation.The photo was visually inspected at becton dickinson and the incident could be verified.A device history record could not be evaluated as the lot number is unknown.A capa has been opened for this issue.An in-depth investigation as part of that capa has been performed to identify the cause of the surgiphor bottle cracking during use.At this time this investigation discovered that the combination of the following variables are probable causes that contribute to the failure mode of surgiphor containers cracking during use: aging, bottle wall thickness/bottle weight, inspected product returned into the manufacturing lot, and upper end of the gamma sterilization dosages of the product.A follow-up will be sent if additional information is received.
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Search Alerts/Recalls
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