MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ DRUG VIAL ACCESS DEVICE; INTRAVASCULAR ADMINISTRATION SET

Model Number	515117
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
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¿ drug vial access device experienced flow issue.The following information was provided by the initial reporter: this is a report about a flow issue of the protector p55.According to the customer's report, during the anticancer agent (abraxane) preparation, the hcp attempted to administer saline but it did not flow.
Event or Problem Description
It was reported that the bd phaseal¿ drug vial access device experienced flow issue.The following information was provided by the initial reporter: this is a report about a flow issue of the protector p55.According to the customer's report, during the anticancer agent (abraxane) preparation, the hcp attempted to administer saline but it did not flow.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 30-jun-2023.H6: investigation summary sample received by our quality team for investigation.Upon visual evaluation, the tip of the protector spike is observed to be bent.A device history review was performed for the reported lot 2204114, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this incident.Five retained samples of the same lot were used for additional evaluation.The retained samples along with the unused product returned were inspected and no damage to the protector spikes was observed.The product undergoes visual and functional testing throughout manufacturing to ensure the quality and functionality of the device.While we could not identify a direct issue, it was determined the damage likely occurred during the assembly process when the piece moved between machines.

• Brand Name: BD PHASEAL¿ DRUG VIAL ACCESS DEVICE
• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16946416
• Report Number: 3003152976-2023-00180
• Device Sequence Number: 2381845
• Product Code: ONB
• UDI-Device Identifier: 00382905151170
• UDI-Public: (01)00382905151170
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/30/2023

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 Model Number: 515117
• Device Catalogue Number: 515117
• Device Lot Number: 2204114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2022
• 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