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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IV SET,MICROSET, Y CONN, FLUSH,SR,STRET; INTRAVASCULAR ADMINISTRATION SET
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IV SET,MICROSET, Y CONN, FLUSH,SR,STRET; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 120-160XCSEK
Device Problem Free or Unrestricted Flow (2945)
Patient Problem Air Embolism (1697)
Event Date 06/17/2021
Event Type  malfunction  
Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this bd device may have been manufactured.A lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical 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.
 
Event Description
It was reported that air entered the iv set,microset, y conn, flush,sr,stret line due to a defective/disengage clamp.The icu consultant was called in to intervene with imaging.It was also reported that there was exposure to blood/bodily fluid.The following information was provided by the initial reporter: ''i am reporting an incident that occurred on our icu with a patient who had a bd pca infusion set connected to the patient on (b)(6) 2021.The patient had a pca connected for pain control and in the subsequent few hours hence became more and more breathless.The icu consultant who was called to review saw air in the right side of the heart and traced the source of the air to the y connector that was not being used to administer fluid, was capped with the supplied cap but the white clamp was disengaged." "it was noted that the supplied cap was not sealing appropriately despite being screwed on.Despite the clamp being disengaged we would expect this to still fail safe.A colleague and i have been able to test another pca set from the same range and have been able to entrain air via a capped y connector' exposure to blood/bodily fluid-yes".
 
Manufacturer Narrative
H6: investigation summary a 120-160xcsek product was not available for investigation, however the customer indicates that air ingressed through the cap of the y-port during infusion.The customer indicates that the cap was screwed onto the female luer, however the slide clamp was not closed.As part of the investigation, the customer provided a photograph of the affected product however no obvious manufacturing defects were visible which may have contributed to the customer's experience.The details of this feedback were shared with the legal manufacturer of the product, caesarea medical electronics ltd, for investigation.The lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.The root cause of the customer¿s experience could not be determined as the sample was not available for investigation.In this instance, without a sample it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.A review of the customer feedback database indicates that this is an isolated occurrence with no further reports of this nature against the 120-160xcsek product over the past 12 months.H3 other text : see h10.
 
Event Description
It was reported that air entered the iv set,microset, y conn, flush,sr,stret line due to a defective/disengage clamp.The icu consultant was called in to intervene with imaging.It was also reported that there was exposure to blood/bodily fluid.The following information was provided by the initial reporter: ''i am reporting an incident that occurred on our icu with a patient who had a bd pca infusion set connected to the patient on (b)(6) 2021.The patient had a pca connected for pain control and in the subsequent few hours hence became more and more breathless.The icu consultant who was called to review saw air in the right side of the heart and traced the source of the air to the y connector that was not being used to administer fluid, was capped with the supplied cap but the white clamp was disengaged." "it was noted that the supplied cap was not sealing appropriately despite being screwed on.Despite the clamp being disengaged we would expect this to still fail safe.A colleague and i have been able to test another pca set from the same range and have been able to entrain air via a capped y connector' exposure to blood/bodily fluid-yes.".
 
Event Description
It was reported that air entered the iv set,microset, y conn, flush,sr,stret line due to a defective/disengage clamp.The icu consultant was called in to intervene with imaging.It was also reported that there was exposure to blood/bodily fluid.The following information was provided by the initial reporter: ''i am reporting an incident that occurred on our icu with a patient who had a bd pca infusion set connected to the patient on the (b)(6) 2021.The patient had a pca connected for pain control and in the subsequent few hours hence became more and more breathless.The icu consultant who was called to review saw air in the right side of the heart and traced the source of the air to the y connector that was not being used to administer fluid, was capped with the supplied cap but the white clamp was disengaged."."it was noted that the supplied cap was not sealing appropriately despite being screwed on.Despite the clamp being disengaged we would expect this to still fail safe.A colleague and i have been able to test another pca set from the same range and have been able to entrain air via a capped y connector' exposure to blood/bodily fluid-yes".
 
Manufacturer Narrative
Correction: after further review, it was clarified that the cme set reported is not sold in the us.This report will be cancelled.
 
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Brand Name
IV SET,MICROSET, Y CONN, FLUSH,SR,STRET
Type of Device
INTRAVASCULAR ADMINISTRATION SET
MDR Report Key12215629
MDR Text Key265892243
Report Number2243072-2021-01955
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup,Followup
Report Date 10/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number120-160XCSEK
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received10/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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