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

Model Number	515004
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.Device manufacture date: unknown.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 flow issues occurred during use with a bd phaseal¿ injector luer lock n35c.The following information was provided by the initial reporter, "the phaseal luer lock connector (c35) did not allow any injection, after connected to the injector.The phaseal connector and the phaseal injector was therefor taken off, and the injection was given without the projection from the phaseal devices." update afer asking if the defect is clog: "the problem was, that there was no access.".
Additional Manufacturer Narrative
H.6.Investigation summary: no photos or physical samples that display the reported condition were available for investigation.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.H3 other text : see section h.10.
Event or Problem Description
It was reported that flow issues occurred during use with a bd phaseal¿ injector luer lock n35c.The following information was provided by the initial reporter, "the phaseal luer lock connector (c35) did not allow any injection, after connected to the injector.The phaseal connector and the phaseal injector was therefor taken off, and the injection was given without the projection from the phaseal devices.Update afer asking if the defect is clog: "the problem was, that there was no access.".

• 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: 9759370
• Report Number: 3003152976-2020-00086
• Device Sequence Number: 14180523
• 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): 02/28/2020

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 Model Number: 515004
• Device Catalogue Number: 515004
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 02/28/2020
• 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