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Catalog Number 4007 |
Device Problem
Delivered as Unsterile Product (1421)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/05/2022 |
Event Type
malfunction
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Event Description
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It was reported that, during infusion, while immobilizing with an iv3000 1 hand 6x7cm ctn 100 dressing, the package was discovered to be broken and was immediately replaced with no harm to the patient.Upon feedback it was informed that this may have been caused by storage problem by the hospital.No further information is available at this time.
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Manufacturer Narrative
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Internal complaint number: (b)(4).
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Manufacturer Narrative
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H3, h6: the device was not returned for evaluation.All provided information has been reviewed and we have not been able to establish a relationship between the device and the reported event or determine a root cause.There are strict inspections during the manufacturing process to ensure that products that do not meet specifications are rejected.Based on feedback the probable cause is hospital storage problem.A review of the batch manufacturing records could not be performed as the lot number provided (20211001) is not a valid lot number for this product.However, there are no indications to suggest that the device did not meet specifications upon release to distribution.A review of complaint history did not reveal similar events for this nature with no manufacturing problems observed.A risk management review concluded that the alleged failure mode and any associated harm has been anticipated within the risk file, with no updates required.A review of prior escalation actions found no actions applicable to the scope of this case.This investigation is now complete with no further action deemed necessary.Smith and nephew will continue to monitor for any adverse trends relating to this product range.
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Search Alerts/Recalls
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