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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the bd phaseal¿ connector luer lock (c35) leaked.The following information was provided by the initial reporter: "product is leaking (multiple occurrences).".
Additional Manufacturer Narrative
H6: investigation summary: no samples or photos received for investigation.Three retained samples from the same lot were evaluated, no issues or defects observed.Also, all of them could be properly connected to a matting component.Leakage testing is performed for all lots during manufacturing to ensure the quality of the membrane.A device history review was performed for the reported lot 2104203, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.The performance of the sealing membrane is reduced after multiple perforations and extended activation time.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.
Event or Problem Description
It was reported that the bd phaseal¿ connector luer lock (c35) leaked.The following information was provided by the initial reporter: "product is leaking (multiple occurrences).".

• 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
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12624719
• Report Number: 3003152976-2021-00683
• Device Sequence Number: 19142331
• Product Code: ONB
• UDI-Device Identifier: 30382905152000
• UDI-Public: 30382905152000
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

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: 03/31/2025
• Device Model Number: 515200
• Device Catalogue Number: 515200
• Device Lot Number: 2104203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2021
• Supplement Date Received by Manufacturer: 11/09/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown