MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL CONNECTOR LUER LOCK C35

Model Number	515200
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/15/2020
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 is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the bd phaseal¿ connector luer lock c35 experienced device damage/deformation while still considered operable.The following information was provided by the initial reporter: during quality inspection, the membrane of c35 was found to be damaged.
Additional Manufacturer Narrative
H6: investigation summary no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for lot 1907109, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Five retained samples of the same lot were used for additional evaluation.The product was visually inspected and no defects were identified with the membrane and all membranes were properly positioned.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.A vision system is used to verify the proper welding of the membrane and detect for any missing or incorrectly placed membranes.The system was challenged after receiving this complaint, placing 15 connectors with missing membranes within the camera station, in all cases the product was properly identified and discarded.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.
Event or Problem Description
It was reported that the bd phaseal¿ connector luer lock c35 experienced device damage/deformation while still considered operable.The following information was provided by the initial reporter: during quality inspection, the membrane of c35 was found to be damaged.

• Brand Name: BD PHASEAL CONNECTOR LUER LOCK C35
• Common Device Name: PHASEAL CONNECTOR
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 10796329
• Report Number: 3003152976-2020-00488
• Device Sequence Number: 3489941
• Product Code: ONB
• UDI-Device Identifier: 30382905152000
• UDI-Public: 30382905152000
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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: Other
• Device Expiration Date: 06/30/2023
• Device Model Number: 515200
• Device Catalogue Number: 515200
• Device Lot Number: 1907109
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 11/05/2020
• Supplement Report FDA Received Date: 12/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1