SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ANESTHESIA BREATHING CIRCUIT; CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)
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Catalog Number C45101340-NLJ |
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 07/01/2022 |
Event Type
malfunction
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Event Description
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It was reported that before opening the package, the customer found an insect in it.No patient injury was reported.No additional information is available.
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Manufacturer Narrative
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A product sample was received and is awaiting evaluation and investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Protocol # and the udi are unknown, no product information has been provided to date.
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Manufacturer Narrative
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Other text: h6: event problem and evaluation codes: updated.H10: device evaluation: the device was returned for investigation.Four (4) pictures were attach, during the analysis conducted it could be observed a top view of a circuit breathing inside of sealing packaging, two of them is made a focus to a section where foreign matter that looks like parts of insect is observed.Visual inspection results: the bag of the circuit breathing is sealed and a particle of foreign matter that looks like part of insect was detect; thus failure mode reported is confirmed.Additionally, the plastic bag of the sample returned it was inspected and confirmed the presence of 2 holes, which is within specification; this both holes were received cover with tape and position is close to the connector which contamination was detected.However, due bag has an opening it can not be confirmed that the defect was caused during the manufacturing process.The most probable root cause occurred after the product left smiths medical facilities.The cause of the reported problem could not be determined.A dhr (device history review) was performed and no problems or issues were identified during this dhr review.
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