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Catalog Number 2N3399 |
Device Problem
Packaging Problem (3007)
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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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Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that an unspecified quantity of interlink system injection sites were upside down inside the packaging; so "when they opened it up, they are touching the area that should not be touched.".This was observed before use.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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D4: lot # sr21e14100 d4: unique identifier (udi) #: (b)(4).H10: the actual device was not available; however, two (2) photographs of the sample were provided for evaluation.A visual inspection was performed to the photograph using the naked eye which did not identify any abnormalities that could have contributed to the reported condition.The reported sample was packed with correct part orientation in the blister pack.Therefore, the reported problem could not be verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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