Catalog Number MP1000 CHINA |
Device Problem
Complete Blockage (1094)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/05/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
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Event Description
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It was reported that bd maxplus needleless connector was occluded the following information was received by the initial reporter with the following verbatim: the patient was suffering from aplastic anaemia resulting in a decrease in whole blood cells requiring transfusion for symptomatic treatment, and was given an intravenous blood transfusion on (b)(6) 2023 at 11:16 a.M.During the transfusion, it was found that the fluid was not draining, and after checking the intravenous line, there was no abnormality, and after giving a replacement of a new needleless connector, the drip flowed smoothly.
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Manufacturer Narrative
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Additional information: additional event details added to b5.Initial reporter name added.Investigation results: no samples were received for investigation of (b)(4), in which the customer has stated: ¿the fluid was not draining¿.The product in use at the time is reported to be a mp1000 china from lot 23025311.Further information provided by the customer confirmed that there were no damages on the product and leakage was not observed.The customer also reported that the flow was completely blocked.The details of this feedback were forwarded to the manufacturing site for investigation, where a review of the production records for lot 23025311 did not identify any in-process testing failures or quality deviations which may have caused or contributed to a report of this nature.The root cause of the customer¿s experience could not be determined in this instance as no sample was received for investigation.Without a sample to examine it is not possible to determine whether a manufacturing defect could have caused or contributed to a report of this nature.Previous investigations have identified that certain designs of male luer can cause flow restriction or occlusion as they can grip onto the piston of the maxplus preventing its proper collapse.This can sometimes be resolved by disconnecting and reattaching the same luer connection which may reposition the luer against the piston and improve the flow, or alternatively by changing the connecting male luer.In this instance, without the complaint sample to examine it has not been possible to conclusively link this feedback to a specific failure mode; however, a review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the mp1000 china products in the past 12 months.
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Event Description
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Additional information: please can you confirm if there are any visible defects to the device i.E., cracks, flashes, kinks? no.Please confirm whether the flow was completely or partially blocked? completely blocked.Please can you confirm if leakage was observed.No.
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Search Alerts/Recalls
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