Model Number 70-0060-114 |
Device Problem
Fracture (1260)
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Patient Problem
Feeding Problem (1850)
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Event Date 03/02/2018 |
Event Type
malfunction
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Manufacturer Narrative
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No patient information was available.Event date is estimated based upon report date (event date may be earlier).This mdr groups four complaints which are on the same model number and for the same issue.Entered date is earliest of the four.The remaining three were reported on 3/12/2018, 3/19/2018 and 3/30/2018.Model number is xeridiem part number.Catalog number is part number for cook medical, xeridiem's exclusive distributor for this device.Since lot number is unknown, expiration date and full udi are not known.Implant/explant dates are not known.Device sample was returned on one of the four complaints and may be returned on one more.Date of return is estimated based upon date of evaluation.A follow-up report will only be provided if there is a different finding on the last return.Initial reporter listed was for three of the four complaints.The other complaint was reported by casey lester, (b)(4).Date listed is for first of the 4 complaints.The other three were reported on 3/12/2018, 3/19/2018 and 3/30/2018.Evaluation completed on 1 returned device.One more device return is anticipated.Date of manufacture cannot be determined since lot number is unknown.Conclusion code indicates the known issue which is resolved by change recently cleared in k171347.Xeridiem is presently working through production implementation of this change.
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Event Description
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The enfit caps and feeding port connections are breaking.There are small cracks in the caps themselves and the threaded flanges are breaking off.The patient is also using tools to get caps unstuck.The caps need to be tightened down hard or else they leak.The enfit that is glued into tube is breaking when patients try to wiggle the enfit connection out of the feeding ports.
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Event Description
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Same as original report 2025851-2018-00006.
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Manufacturer Narrative
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This follow-up report adds three additional complaint reports that are from the same healthcare facility, on the same device catalog number, and for the same issue as the original mdr.Date entered is for the first additional report.The other two additional reports were received on may 21, 2018 and june 29, 2018.Product was returned on the first of these additional complaints and the enfit connector cracking failure was confirmed but with no new finding as compared to the original mdr.As stated in the original mdr, xeridiem is currently working through production implementation of the change (enfit connector material) that corrects this problem.
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Search Alerts/Recalls
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