MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL INJECTOR LUER LOCK N35C; INTRAVASCULAR ADMINISTRATION SET

Model Number	515004
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that when the bd phaseal¿ injector luer lock n35c was connected to the flush syringe, the syringe was "not possible" to push down during use.As a result, the phaseal leaked "cytostatics" and had to be removed, while the flush syringe was connected directly to the patient's ic-access.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "when the phaseal injector (n31) was connected to a 20 ml.Flush syringes, it has in more than one case being a problem, that it is not possible to push the flush syringes down.That makes it necessary for the staff to take the phaseal part off, and connect the flush syringes directly to the patients ic-access." "the staff and the patient get exposed to cytostatics".
Additional Manufacturer Narrative
H.6.Investigation summary no photos or samples that display the reported condition were available for investigation.A device history review was performed for reported lot 1905109, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Product undergoes testing and inspections throughout the manufacturing process.All results were reviewed for lot 1905109 with no issues identified.Three retained samples of the same lot were used for additional evaluation.The samples were functionally tested, solution was withdrawn from a vial, then connecting the syringe and injector to sample connectors.In all cases the product functioned properly, liquid passed through the system, and no flow issues were observed.Based on the available information we are not able to identify a root cause at this time.Complaints received for this defect and device will continue to be monitored by our quality team for signs of emerging trends.
Event or Problem Description
It was reported that when the bd phaseal¿ injector luer lock n35c was connected to the flush syringe, the syringe was "not possible" to push down during use.As a result, the phaseal leaked "cytostatics" and had to be removed, while the flush syringe was connected directly to the patient's ic-access.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "when the phaseal injector (n31) was connected to a 20 ml.Flush syringes, it has in more than one case being a problem, that it is not possible to push the flush syringes down.That makes it nessecary for the staff to take the phaseal part off, and connect the flush syringes directly to the patients ic-acess." "the staff and the patient get exposed to cytostatics".

• Brand Name: BD PHASEAL INJECTOR LUER LOCK N35C
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 9945618
• Report Number: 3003152976-2020-00162
• Device Sequence Number: 2897536
• Product Code: ONB
• UDI-Device Identifier: 30382905150044
• UDI-Public: 30382905150044
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K140591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

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
• Operator of Device: Other
• Device Expiration Date: 10/31/2021
• Device Model Number: 515004
• Device Catalogue Number: 515004
• Device Lot Number: 1905109
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2020
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other