SMITHS MEDICAL ASD, INC. MEDEX EXTENSION SETS SINGLE LINE; SET, ADMINISTRATION, INTRAVASCULAR
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Model Number 537240PS |
Device Problem
Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/11/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Other text: e4: initial reporter also sent report to fda? unknown.H6: event problem and evaluation codes: updated.H10: device evaluation: two sample was returned for investigation.The samples were received in used condition without the original package.Returned samples were tested for water leak; returned samples exhibited occlusion condition.The samples were also visually inspected under a microscope to detect the cause of obstruction.It was observed that the internal diameter of the tube was obstructed.The occlusion condition found on returned samples is related to a supplier issue.An awareness meeting with operators and quality inspectors about the failure mode reported on this complaint was held.A device history record (dhr) was performed, and no issues or deviations were observed during the manufacturing of this lot.An internal scar has been opened and this issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional corrective actions will be taken.This remediation mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).
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Event Description
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It was reported that a patient was infused with adrenaline, however the medication was not flowing through due to an obstruction in the line.The medical staff noticed the obstruction while purging and preparing the equipment.No patient injury reported.
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Search Alerts/Recalls
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