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Catalog Number 21-7036-01 |
Device Problem
Leak/Splash (1354)
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Patient Problem
Complaint, Ill-Defined (2331)
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Event Type
Injury
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Manufacturer Narrative
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Voluntary medwatch submission #: mw5066842.Event date: the reporter noted that the event occurred "(b)(6) 2016 thru present" and "summer 2016".It was reported that (b)(6) 2016 was the earliest date of related reports.Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
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Event Description
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It was reported that a cadd® extension set was leaking at the cassette.The patient may have required additional treatment.It is unclear what the impact to the patient was.See mfr: 3012307300-2017-00383, 3012307300-2017-00384, 3012307300-2017-00385, 3012307300-2017-00386, 3012307300-2017-00387, 3012307300-2017-00388, 3012307300-2017-00389, 3012307300-2017-00390, 3012307300-2017-00391, 3012307300-2017-00392, 3012307300-2017-00393, 3012307300-2017-00394, 3012307300-2017-00395, 3012307300-2017-00396, 3012307300-2017-00397, 3012307300-2017-00398, 3012307300-2017-00399, 3012307300-2017-00400, 3012307300-2017-00401, 3012307300-2017-00402, and 3012307300-2017-00403.
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Manufacturer Narrative
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Additional information was received that detailed that this incident had been captured previously.The following is a list of reported mfrs related to this mdr: 3012307300-2017-00404, 3012307300-2017-00405, 3012307300-2017-00406, 3012307300-2017-00407, 3012307300-2017-00408, 3012307300-2017-00409, 3012307300-2017-00410, 3012307300-2017-00411, 3012307300-2017-00412, 3012307300-2017-00413, 3012307300-2017-00414, 3012307300-2017-00415, 3012307300-2017-00416, 3012307300-2017-00417, 3012307300-2017-00418, 3012307300-2017-00419, 3012307300-2017-00421, 3012307300-2017-00422, 3012307300-2017-00423, 3012307300-2017-00659, 3012307300-2017-00660, 3012307300-2017-00661, 3012307300-2017-00662, 3012307300-2017-00663, 3012307300-2017-00664, and 3012307300-2017-00665.Upon further review, this file is considered a duplicate and it is not considered a reportable event at this time.
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Search Alerts/Recalls
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