MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL CONNECTOR LUER LOCK (C35); INTRAVASCULAR ADMINISTRATION SET

Model Number	515200
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone#: (b)(6).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¿ connector luer lock (c35) does not fit.This was discovered during use.The following information was provided by the initial reporter: doxorubicin adapter does not fit to inject the chemotherapy product.The adapter was discarded.For some time, nurses have been experiencing difficulties in correctly adapting the connector c35 phaseal to the injector n35, making its use impossible.Nurses are therefore obliged to remove the injector (which is adapted by the pharmacy when the syringe is reconstituted), risking exposure to the chemotherapy product contained in the syringe.In the case cited in this statement, the nurse removed the injector to dispense the product.The patient completed the entire course of treatment.The syringe assembly, connector and injector have not been kept.
Additional Manufacturer Narrative
H.6.Correction: new guidelines have been issued stating: when the connector is not able to or difficult to connect to the injector, this may lead to customer dissatisfaction as a new connector is required but does not lead to any degree of harm/serious injury.The new guidelines supersede previous mdr.Due to this new information this event is no longer reportable as a malfunction.This event was over reported.H3 other text : see h.10.
Event or Problem Description
It was reported that bd phaseal¿ connector luer lock (c35) does not fit.This was discovered during use.The following information was provided by the initial reporter: doxorubicin adapter does not fit to inject the chemotherapy product.The adapter was discarded.For some time, nurses have been experiencing difficulties in correctly adapting the connector c35 phaseal to the injector n35, making its use impossible.Nurses are therefore obliged to remove the injector (which is adapted by the pharmacy when the syringe is reconstituted), risking exposure to the chemotherapy product contained in the syringe.In the case cited in this statement, the nurse removed the injector to dispense the product.The patient completed the entire course of treatment.The syringe assembly, connector and injector have not been kept.
Event or Problem Description
It was reported that bd phaseal¿ connector luer lock (c35) does not fit.This was discovered during use.The following information was provided by the initial reporter: doxorubicin adapter does not fit to inject the chemotherapy product.The adapter was discarded.For some time, nurses have been experiencing difficulties in correctly adapting the connector c35 phaseal to the injector n35, making its use impossible.Nurses are therefore obliged to remove the injector (which is adapted by the pharmacy when the syringe is reconstituted), risking exposure to the chemotherapy product contained in the syringe.In the case cited in this statement, the nurse removed the injector to dispense the product.The patient completed the entire course of treatment.The syringe assembly, connector and injector have not been kept.
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 1905113, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Three 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, properly connecting a sample syringe and injector onto the retained connector samples.The injector was disengaged and the process was repeated five times, in all cases the product functioned properly, and no issues were observed.Product undergoes visual and functional testing throughout manufacturing to ensure the quality and functionality of the device.Based on the available information we are not able to identify a root cause at this time.It is important to follow the instructions for use when using phaseal devices to ensure the product functions properly.Complaints received for this defect and device will continue to be monitored by our quality team for signs of emerging trends.

• Brand Name: BD PHASEAL CONNECTOR LUER LOCK (C35)
• 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: 10052340
• Report Number: 3003152976-2020-00203
• Device Sequence Number: 14423442
• Product Code: ONB
• UDI-Device Identifier: 30382905152000
• UDI-Public: 30382905152000
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123213
• 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,Followup
• Report Date (Section B): 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 515200
• Device Catalogue Number: 515200
• Device Lot Number: 1905113
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 04/23/2020; 04/23/2020
• Initial Report FDA Received Date: 05/13/2020
• Supplement Report FDA Received Date: 06/19/2020; 06/26/2020
• 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