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	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that leakage occurred from between the bd phaseal¿ connector luer lock (c35) and the needle during use.The following information was provided by the initial reporter: "multiple issues of leakage in the connection between the connector and a needle.".
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.
Event or Problem Description
It was reported that leakage occurred from between the bd phaseal¿ connector luer lock (c35) and the needle during use.The following information was provided by the initial reporter: "multiple issues of leakage in the connection between the connector and a needle.".

• 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: 9721551
• Report Number: 3003152976-2020-00065
• Device Sequence Number: 14220264
• Product Code: ONB
• UDI-Device Identifier: 30382905152000
• UDI-Public: 30382905152000
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 02/20/2020

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: 515200
• Device Catalogue Number: 515200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 01/29/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 02/20/2020
• 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