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	02/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd phaseal¿ injector luer lock n35c leaked during use.The following information was provided by the initial reporter: the compounding unit are sending in a complaint about a injector that are leaking and you couldn't inject anything through it.They couldn't see any damage on it and they are saying it look good and ok.But it leaked and it where a kind of "vacuum" and you couldn't inject any cytotoxic through the injector.Update the 9th of march: when administering im bleomycin, i notice that the syringe is leaking and the drug in the syringe drips to the side.So no drug enters the patient.I remove the syringe to see if i can see any error in the connection with phaseal or the needle.I change the cannula and try again, i administer about 1 ml of the drug again but when i release a little finger there is a back suck in the phaseal clutch and the syringe goes back to the ml where i started on, so no drug has been administered.Patient with mdg treatment, when the 5-fu syringe is to be switched on, it is not possible to thread the phaseal connection.A colleague may replace the phaseal injector to a new one in the capinet.When fluorouracil syringe is to be given, it is signed in a secure injection valve phaseal luerlock and starts injecting, then immediately detects that it is leaking a few drops.Phaseal on the flv syringe did not work, the blue part could not be pressed down.The syringe had to be given without phaseal.
Event or Problem Description
It was reported that bd phaseal¿ injector luer lock n35c leaked during use.The following information was provided by the initial reporter: the compounding unit are sending in a complaint about a injector that are leaking and you couldn't inject anything through it.They couldn't see any damage on it and they are saying it look good and ok.But it leaked and it where a kind of "vacuum" and you couldn't inject any cytotoxic through the injector.Update the 9th of march: when administering im bleomycin, i notice that the syringe is leaking and the drug in the syringe drips to the side.So no drug enters the patient.I remove the syringe to see if i can see any error in the connection with pha seal or the needle.I change the cannula and try again, i administer about 1 ml of the drug again but when i release a little finger there is a back suck in the pha seal clutch and the syringe goes back to the ml where i started on, so no drug has been administered.- patient with mdg treatment, when the 5-fu syringe is to be switched on, it is not possible to thread the phaseal connection.A colleague may replace the phaseal injector to a new one in the capinet.- when fluorouracil syringe is to be given, it is signed in a secure injection valve phaseal luerlock and starts injecting, then immediately detects that it is leaking a few drops.- phaseal on the flv syringe did not work, the blue part could not be pressed down.The syringe had to be given without phaseal.
Additional Manufacturer Narrative
H.6.Investigation: no photos or samples that display the reported condition were available for investigation.A device history review was performed for reported lot 1908104, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported issue.Product undergoes inspections throughout the manufacturing process.Six retained samples of the same lot were used for additional evaluation.The samples were visually inspected, no damage or defects was observed on any of the injectors.Dimensional testing was completed, verifying the luers were within required specification.Three of 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, luer connections were secure, liquid passed through the system without issue, and no leakages were identified.Leakage testing was then performed on the three additional retained samples to ensure the quality of the membrane.All results were found to be acceptable with no leaks identified.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.

• 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: 9812309
• Report Number: 3003152976-2020-00113
• Device Sequence Number: 19539930
• Product Code: ONB
• UDI-Device Identifier: 30382905150044
• UDI-Public: 30382905150044
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 04/28/2020

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: 01/31/2022
• Device Model Number: 515004
• Device Catalogue Number: 515004
• Device Lot Number: 1908104
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 04/28/2020
• 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