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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL INJECTOR LUER LOCK N35; INTRAVASCULAR ADMINISTRATION SET
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BECTON DICKINSON, S.A. BD PHASEAL INJECTOR LUER LOCK N35; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 515003
Device Problem Leak/Splash (1354)
Patient Problem Skin Irritation (2076)
Event Date 08/20/2020
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that the syringe "blew off" while injecting air into the vial using the bd phaseal¿ injector luer lock n35 and protector, splashing chemo in the employee's face.Although eyewear was worn, the employee used the eye wash and followed up with employee health.The event of luer connection breakage occurred 4 times during use, and this complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter: "pharmacy director wants to report a complaint with the phaseal system.She states while injecting air into a vial using phaseal protector 515105 and phaseal injector 515003, the syringe "blew off" and the chemo drug cyranza squirted everywhere.She states this has occurred at least 4 other times using these products." "the technician splashed did have to use the eye wash and go to employee health.She had some redness on her cheek but luckily had on eyewear that protected her eyes.She will continue to follow with employee health for any future needs.".
 
Manufacturer Narrative
Investigation summary: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for lot: 2002117, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Two retained samples of the same lot were used for additional evaluation.The product was visually inspected and no defects were identified.Functional testing was performed, connecting the injector to a sample syringe, protector, and vial according to the instructions for use.In all cases the product functioned properly, no disconnections occurred, and no issues were identified with the luer connections.Product undergoes inspections throughout the manufacturing process, including testing to verify all critical dimensions are within specification such as the luer threading.Results were reviewed for the reported lot and no issues were identified.Based on the available information we are not able to identify a root cause related to the connector or our manufacturing process at this time.It is important to ensure all luer connections are securely tightened before use.Complaints received for this defect and device will be monitored by our quality team for signs of emerging trends.
 
Event Description
It was reported that the syringe "blew off" while injecting air into the vial using the bd phaseal¿ injector luer lock n35 and protector, splashing chemo in the employee's face.Although eyewear was worn, the employee used the eye wash and followed up with employee health.The event of luer connection breakage occurred 4 times during use, and this complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter: "pharmacy director wants to report a complaint with the phaseal system.She states while injecting air into a vial using phaseal protector 515105 and phaseal injector 515003, the syringe "blew off" and the chemo drug cyranza squirted everywhere.She states this has occurred at least 4 other times using these products." "the technician splashed did have to use the eye wash and go to employee health.She had some redness on her cheek but luckily had on eyewear that protected her eyes.She will continue to follow with employee health for any future needs.".
 
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Brand Name
BD PHASEAL INJECTOR LUER LOCK N35
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key10516313
MDR Text Key214539221
Report Number3003152976-2020-00405
Device Sequence Number1
Product Code ONB
UDI-Device Identifier30382905150037
UDI-Public30382905150037
Combination Product (y/n)N
PMA/PMN Number
K140591
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 11/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2022
Device Model Number515003
Device Catalogue Number515003
Device Lot Number2002117
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/20/2020
Initial Date FDA Received09/10/2020
Supplement Dates Manufacturer Received11/13/2020
Supplement Dates FDA Received11/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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