Catalog Number 100/800/060CZ |
Device Problem
Moisture or Humidity Problem (2986)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/17/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Protocol number is unknown.No information has been provided to date.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.
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Event Description
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It was reported that there is lots of moisture inside the tube.No injury reported.It was discovered prior to patient use.The outcome of the event was resolved.
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Manufacturer Narrative
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Other, other text: h6: event problem and evaluation codes: updated.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.10 not used (not opened) unit packs were returned for investigation.Under visual inspection the samples appeared to be in good condition.There was not any moisture inside unit packs.Following packaging testing was performed: - dye test was performed on 5pcs.All 5 pcs passed the testing (whole packaging including seal was leak proof).- peel test was performed on 5pcs.All 5 pcs passed the testing (seal was continuous and met width limit).Based on physical testing the sterile barrier (unit pack) was evaluated as acceptable and there was not found any packaging related nonconformity.Possible explanation of customer observation is that transparent film of unit pack is slightly fuzzy.That might be incorrectly evaluated by customer to be moisture.Despite that transparent film is within all specifications and its visual appearance is normal (in comparison with current and older production).Any similar customer complaint has not been ever received against product.The cause of the reported problem could not be determined as no fault was found with the device.A manufacturing dhr (device history review) was not performed because the results of the complaint investigation do not indicate a problem with the manufacture or last repair of the device.No manufacturing or service issues were identified as causes of the customer reported problem during the review of service and repair records.Therefore, no manufacturing or service records review is needed.
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Search Alerts/Recalls
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