Catalog Number UNKNOWN |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Unknown manufacturer: (b)(4).Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, 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 unspecified bd¿ tubing was missing the clamp.The following information was provided by the initial reporter: material no: unknown batch no: unknown.Event 1: it was reported that the first tubing had no clamp.Event 2: it was reported that the second tubing had no way to connect the tubing to the luer lock on the sister tubing because there was no part to screw onto the other tubing.Event 3: it was reported that the third tubing disconnected at the gtt chamber while priming the tubing.Event 4: it was reported that another disconnected at the y-site after priming.Event 5: it was reported that the positive pressure port has nothing around the blue part (clear surrounding piece is gone).Verbatim: are you able to provide details on the reported failure? the first tubing had no clamp.Second tubing hand no way to connect the tubing to the leur lock on the sister tubing, there was no part to screw onto the other tubing.Third the tubing disconnected at the gtt chamber while priming the tubing, another disconnected at the y site, after priming.I have one that the positive pressure port has nothing around the blue part(clear surrounding piece is gone.) was there any adverse event(s) as a result of the reported defect? o if yes, please provide details, in addition to patient identifiers (initials, sex, dob, diagnosis, etc.).I do believe that this has caused issues with getting medication to the patients but will have to verify.
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Manufacturer Narrative
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H.6.Investigation: one sample was received for quality investigation.The customer complaint of the tubing disconnected at the y-site after priming, misassembly, and drip chamber separating from the tubing, was verified by visual inspection.A device history record review could not be performed because a model or lot number was not provided by the customer.The root cause for the issues observed with this sample is a manufacturing error during assembly.
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Event Description
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It was reported that unspecified bd¿ tubing was missing the clamp.The following information was provided by the initial reporter: material no: unknown batch no: unknown.Event 1: it was reported that the first tubing had no clamp.Event 2: it was reported that the second tubing had no way to connect the tubing to the luer lock on the sister tubing because there was no part to screw onto the other tubing.Event 3: it was reported that the third tubing disconnected at the gtt chamber while priming the tubing.Event 4: it was reported that another disconnected at the y-site after priming.Event 5: it was reported that the positive pressure port has nothing around the blue part (clear surrounding piece is gone).Verbatim: are you able to provide details on the reported failure? the first tubing had no clamp.Second tubing hand no way to connect the tubing to the leur lock on the sister tubing, there was no part to screw onto the other tubing.Third the tubing disconnected at the gtt chamber while priming the tubing, another disconnected at the y site, after priming.I have one that the positive pressure port has nothing around the blue part(clear surrounding piece is gone.) was there any adverse event(s) as a result of the reported defect? o if yes, please provide details, in addition to patient identifiers (initials, sex, dob, diagnosis, etc.).I do believe that this has caused issues with getting medication to the patients but will have to verify.
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Search Alerts/Recalls
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