SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX GENERAL ANESTHESIA SODASORB CO2 ABSORBENT; ABSORBENT, CARBON-DIOXIDE
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Lot Number L02A-0060 |
Device Problem
Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Additional information: udi and pma/510k are unknown.No product information has been provided to date.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.The technician visually saw the damage that was provided in the complaint.The technician email pictures to the supplier to conduct investigation.Based on the supplier's observation from the pictures, the fourth picture sent with the complaint shows the pre-paks on their sides and 10 to a box.The supplier stated this was not what the packaging configuration would look like when produced at manufacture.There are 12 per box, and they are placed in the box in an upright position.The root cause of the reported issue could not be confirmed during evaluation; however, the most probable root cause from the supplier appeared to be that the pre-paks either fell or were taken out of the box, and then were replaced in the incorrect configuration.It was assumed that pre-paks were cracked and the cellophane on the outside of the pre-paks were torn in the process.No actions were taken.
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Event Description
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It was reported that the canisters were supposed be individually wrapped.However, when customer opened the case, the seams on the canister split, and the canisters were cracked.No damaged to the box and it was not re-taped.No patient injury was reported.
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Search Alerts/Recalls
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