MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P55; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515117
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 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¿ protector p55 was leaking.The following was translated from japanese to english: this report is about leakage after attaching the protector.Leakage was confirmed after connecting the endoxan protector (p55).An investigation was requested regarding the leak point and connection.Lot number is currently being confirmed.
Additional Manufacturer Narrative
Pr (b)(4) follow up mdr for device evaluation: two protectors assembled onto a vial were provided to our quality team for investigation.Upon visual evaluation, no defects or issues observed.Functional testing was performed and no leakage outside the system was observed.It was noted the spike penetrated the vial stopper at an angle in one of the samples, creating a puncture hole larger than the diameter of the spike.Product undergoes a series of testing during manufacturing to ensure the quality and functionality of the device.As lot information for this incident was not available, a device history review could not be performed.Based on the investigation results, it was determined that the protector was not properly connected to the vial which damaged the vial stopper and resulted in the leak reported.The protector must be attached completely vertical to the vial.The m12 assembly fixture is recommended to ease the connection of the protector to the vial and must be used in a slow and consistent motion.Complaints received for this device and reported will continue to be monitored by our quality team.See manufacturer narrative.
Event or Problem Description
It was reported that the bd phaseal¿ protector p55 was leaking.The following was translated from japanese to english: this report is about leakage after attaching the protector.Leakage was confirmed after connecting the endoxan protector (p55).An investigation was requested regarding the leak point and connection.The protector was attached manually.We obtained the 2 samples and the samples will be investigated by jfrl.

• Brand Name: BD PHASEAL¿ PROTECTOR P55
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17895943
• Report Number: 3003152976-2023-00445
• Device Sequence Number: 7006524
• Product Code: ONB
• UDI-Device Identifier: 00382905151170
• UDI-Public: (01)00382905151170
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2023

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 Catalogue Number: 515117
• Device Lot Number: UNKNOWN
• 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: 09/15/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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