Catalog Number 2420-0007 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
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Event Description
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It was reported that the gem v/nv 20d 1cv 2ss dehp free experienced component separation.The following information was provided by the initial reporter: complaint 3 of 3.Material no: 2420-0007 batch no: 20093140, unknown.Just wanted to pass along an issue xxxxxxx & her staff have been experiencing on c-pod with our iv tubing pmm# (b)(4).It is separating from where it is connected from the mfg.She said they had some instances last night & again today.I have one of defective ones in my cabinet but here is the lot no from one today.We have a few defective bd alaris pump infusion sets reference 2420-0007.I am not sure if other units are experiencing the same issues.The line is cut.I am not sure how many total products were found on the unit yesterday.I have pulled the defective infusion sets from our stock.These were like this in the original packaging-no appearance of tampering.I notified service center as well this evening.
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Manufacturer Narrative
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H.6.Investigation: no product or photo was returned by the customer.The customer complaint of tubing separation at lower fitment could not be verified due to the product not being returned for failure investigation.The root cause of this failure could not be identified without a failure investigation.A device history record review could not be performed because a valid lot number was not provided by the customer.H3 other text : see h.10.
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Event Description
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It was reported that the gem v/nv 20d 1cv 2ss dehp free experienced component separation.The following information was provided by the initial reporter: complaint 3 of 3 material no: 2420-0007 batch no: 20093140, unknown just wanted to pass along an issue xxxxxxx & her staff have been experiencing on c-pod with our iv tubing pmm# 31068.It is separating from where it is connected from the mfg.She said they had some instances last night & again today.I have one of defective ones in my cabinet but here is the lot no from one today.We have a few defective bd alaris pump infusion sets reference 2420-0007.I am not sure if other units are experiencing the same issues.The line is cut.I am not sure how many total products were found on the unit yesterday.I have pulled the defective infusion sets from our stock.These were like this in the original packaging-no appearance of tampering.I notified service center as well this evening.
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Search Alerts/Recalls
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