SMITHS MEDICAL ASD, INC. JELCO SERIVA IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
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Catalog Number 8363 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
Rupture (2208)
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Event Date 08/21/2022 |
Event Type
Injury
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Manufacturer Narrative
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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 vein rupture occurred when installing the medical device.When pushing the tab, it twisted and opened and was very hard to remove because it gets stuck.No further information is known.
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Manufacturer Narrative
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H10: no product was returned for investigation.The cause of the reported problem could not be determined, and the complaint cannot be confirmed.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.If the product is returned, the manufacturer will reopen this complaint for further investigation.There is no evidence for investigation hence the supplier has only been communicated about the complaint.No device history record (dhr) will be performed.This remediation mdr was generated under protocol b10010579, as a result of warning letter cms# 617147.
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Search Alerts/Recalls
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