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

Catalog Number	515200
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 with a bd phaseal¿ connector luer lock c35.The following information was provided by the initial reporter: (2 of 2 complaints) it was reported that the phaseal products are leaking.
Event or Problem Description
It was reported that leakage occurred with a bd phaseal¿ connector luer lock c35.The following information was provided by the initial reporter: (2 of 2 complaints) it was reported that the phaseal products are leaking.
Additional Manufacturer Narrative
H.6.Investigation summary: no samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident and a root cause could be determined.A device history review could not be completed as no batch number was provided.H3 other text : see section h.10.

• 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: 9174913
• Report Number: 3003152976-2019-00713
• Device Sequence Number: 2972822
• Product Code: ONB
• UDI-Device Identifier: 30382905152000
• UDI-Public: 30382905152000
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/26/2019

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 Catalogue Number: 515200
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 11/26/2019
• 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