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

Catalog Number	515117
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd phaseal¿ protector p55 the stopper dislodged into the vial.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: the customer reported that the product did not penetrate the rubber stopper of the vial and fell into the vial along with the rubber stopper.The product was placed in the assembly fixture and an attempt was made to attach it to the vial, but it did not penetrate the rubber stopper.When the assembly fixture handle was pushed up, the vial's rubber stopper fell into the vial.The drug was paclitaxel.The hospital will notify the manufacturer of the drug if there was no defect with the protector.The vial is returned with the protector.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation: one sample was provided to our quality team for investigation.After inspecting the product, the tip of the spike was observed to be bent, preventing the protector from penetrating the vial stopper, resulting in the stopper being pushed in as reported.A device history review was performed for the reported lot 2302126, no deviations or non-conformances were identified, however, a quality notification was noted related to damaged tips.Impacted product had been discarded and the issues were corrected within the assembly machine.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Based on our quality teams investigation, it was determined the damage occurred during the assembly process when the piece is moved between machines.Manufacturing personnel have been notified of this incident to increase awareness.A project has been initiated to reduce any reoccurrence of this issue.Complaints received for this device and reported condition will continue to be monitored by our quality team for signs of emerging trends.
Event or Problem Description
It was reported while using bd phaseal¿ protector p55 the stopper dislodged into the vial.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: the customer reported that the product did not penetrate the rubber stopper of the vial and fell into the vial along with the rubber stopper.The product was placed in the assembly fixture and an attempt was made to attach it to the vial, but it did not penetrate the rubber stopper.When the assembly fixture handle was pushed up, the vial's rubber stopper fell into the vial.The drug was paclitaxel.The hospital will notify the manufacturer of the drug if there was no defect with the protector.The vial is returned with the protector.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17871135
• Report Number: 3003152976-2023-00433
• Device Sequence Number: 7028613
• 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,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2023

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: Other
• Device Catalogue Number: 515117
• Device Lot Number: 2302126
• 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: 09/20/2023
• Supplement Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2023
• 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