MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR 50; INTRAVASCULAR ADMINISTRATION SET

Model Number	515105
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
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 bd phaseal¿ protector 50 had a leakage issue.The following information was provided by the initial reporter, translated from (b)(6): "upon striking a vial of cyclophosphamide with a protector, the operator notices fluid on the vial which appears to be from leakage related to the insertion of the device.".
Event or Problem Description
It was reported bd phaseal¿ protector 50 had a leakage issue.The following information was provided by the initial reporter, translated from french: "upon striking a vial of cyclophosphamide with a protector, the operator notices fluid on the vial which appears to be from leakage related to the insertion of the device.".
Additional Manufacturer Narrative
H6: investigation summary : no photos or physical samples showing the reported problem were provided for investigation.A device history was performed, and no compliance related to the reported problem was found during the production of lot 2107118.Five retained samples from the same lot were used for further evaluation.The protectors were successfully connected to the vials, ensuring that they fitted correctly.The product was evaluated, and no damage or defects were observed.Functional tests were performed on the samples and no leakage was identified between the protector and the vial.The product undergoes visual and functional testing throughout manufacturing, including leak testing.Results were reviewed for lot 2107118 and found no problems related to the reported event.Based on the available information, we are unable to identify a root cause related to the manufacturing process at this time.

• Brand Name: BD PHASEAL¿ PROTECTOR 50
• 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: 12713750
• Report Number: 3003152976-2021-00712
• Device Sequence Number: 4550659
• Product Code: ONB
• UDI-Device Identifier: 30382905151058
• UDI-Public: 30382905151058
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2021

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: Health Professional
• Device Expiration Date: 06/30/2026
• Device Model Number: 515105
• Device Catalogue Number: 515105
• Device Lot Number: 2107118
• 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: 09/29/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 10/28/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2021
• 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