Catalog Number 306424 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Respiratory Distress (2045); Reaction (2414); Sweating (2444)
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Event Date 04/30/2018 |
Event Type
Injury
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Manufacturer Narrative
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This mdr is intended to report 1 of the 2 events described in the event.Another mdr will be filed for the 2nd incident.(1st event submitted with mdr report# 1911916-2018-00229) the customer's address is unknown.Unknown, washington (wa) , 0000 usa has been used as a default.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
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Event Description
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¿it was reported that on two occasions ((b)(6)), after 30 minutes of pushing iv saline, patient experienced a severe reaction (coughing, couldn't breathe, cold sweats).Patient also used heparin flush but thinks the issue was from the saline more so than the heparin.Patient went to the er on both occasions and was told that nothing was able to be determined.Er checked the patient's lungs, checked for embolism, etc.¿ there was no additional specific information on the medical interventions received.
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Manufacturer Narrative
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Five samples were received by bd for evaluation.A quality engineer was able to inspect the samples and sent them out for ftir testing.The results of the testing were all negative and the samples passed each of test.The tests performed were an endotoxin test, ph test, sterility test, and heavy metals and iron testing.All samples were found to be within specifications and there was no observed bacterial growth when plated and incubated.Bd was unable to identify a cause for the reported issue.Bd has placed controls in their manufacturing plants to prevent contamination such as weekly bioburden testing, an overkill sterilization process, biweekly environmental testing with the filling area, the solutions are filtered twice before filling, each sterilizer was thoroughly validated before use and a continuous online monitoring of the wfi water quality.There was no documentation of issues for the complaint of batch 716087n during this production run.There was no documentation of issues for the complaint of batch 723060n during this production run.Capa not required for this event.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.
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Search Alerts/Recalls
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