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	11/15/2019
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 leakage is occurring from the membrane with a bd phaseal¿ injector luer lock n35c.The following information was provided by the initial reporter: university hospital have been using phaseal for years.Now realized, that when using n35 injector small amounts is ¿leaked¿ drug without pushing syringe.Now they are wondering how much of drug is missing for the treatment.The drug used was dactinomycin (1 ml).Additional information received 2019-12-03: the leak was from the membrane of the injector.
Additional 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 1906110, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.During manufacturing, leakage testing is performed, penetrating the injector ten times to verify if any leaks occur.Testing was reviewed for injector lot 1906110, all results were found to be within specification.Five retained samples of the same lot were used for additional evaluation.Functional testing was performed, penetrating the injector along with a sample connector ten times, all results were found to be acceptable with no leaks identified.The injectors were then connected to sample protector, vial, and syringe.Liquid was withdrawn from the vial into the syringe, again no leaks were observed.Investigation conclusion 5 retained samples were evaluated, and no leakage was found through phaseal membrane.Root cause description the defect couldn't be duplicated using the retained samples.No leak was found in any of the six injectors evaluated.No non-conformances found during dhr review that could be involved in the incidence reported.No issues were found in lot release testing (see attached results from assembly lots 9165552 and 9165553).Therefore; the incidence reported could not be replicated and root cause cannot be determined at this time.Rationale the defect couldn't be duplicated.According to qda, cpm for this defect is acceptable.No more actions needed.Complaint will be continue monitored for trends.
Event or Problem Description
It was reported that leakage is occurring from the membrane with a bd phaseal¿ injector luer lock n35c.The following information was provided by the initial reporter: university hospital have been using phaseal for years.Now realized, that when using n35 injector small amounts is ¿leaked¿ drug without pushing syringe.Now they are wondering how much of drug is missing for the treatment.The drug used was dactinomycin (1 ml).Additional information received (b)(6) 2019: the leak was from the membrane of the injector.

• 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: 9402996
• Report Number: 3003152976-2019-00819
• Device Sequence Number: 2738929
• Product Code: ONB
• UDI-Device Identifier: 30382905150044
• UDI-Public: 30382905150044
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 01/13/2020

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
• Operator of Device: Other
• Device Expiration Date: 11/30/2021
• Device Model Number: 515004
• Device Catalogue Number: 515003
• Device Lot Number: 1906110
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 12/03/2019
• Supplement Report FDA Received Date: 01/13/2020
• 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