Catalog Number 21-7231-24 |
Device Problems
Fluid/Blood Leak (1250); Material Fragmentation (1261)
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Patient Problems
Skin Irritation (2076); Chemical Exposure (2570); Device Embedded In Tissue or Plaque (3165)
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Event Type
malfunction
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Manufacturer Narrative
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It was initially reported that the event occurred on (b)(6) 2017, however, the medical report notes from (b)(6) 2017 states the event happened "yesterday".The exact date is unknown.The device is currently being evaluated; smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.Device evaluation in progress.
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Event Description
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It was reported that the plastic cannula of a cleo® 90 infusion set broke off inside the patient's abdomen during infusion set removal.The fault was noticed by the patient's wife and home care nurse.The site had been cleaned with chlorhexidine prior to insertion.The set had been in use for 24 hours at the time of the event.As a result of the event, apomorphine flowed back out of the cannula and onto the patient's skin, which caused small wounds around the infusion set site.It was observed that the wounds looked "calm" and were healing.The patient consulted with a medical specialist regarding the event.The medical specialist decided not to remove the cannula, and to let the cannula "outgrow" itself.No permanent injury was reported.See mfr: 3012307300-2017-01123 and 3012307300-2017-01124.
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Manufacturer Narrative
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Three devices were returned for evaluation in unused condition.Visual inspection of the devices found no anomalies.Functional testing involved simulation testing and did not detect detachment or cannula removal issues.A review of the testing and inspection documents was performed and deemed adequate and correct.A review of the manufacturing process was performed on a similar part and found no discrepancies.Three devices from the manufacturing line were functionally tested and detected no detachment or cannula removal issues.Based on the evidence, a root cause was unable to be determined.No fault was found with the devices.
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Search Alerts/Recalls
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