MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR (P14); INTRAVASCULAR ADMINISTRATION SET

Model Number 515100

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2022

Event Type  malfunction  

Event Description

It was reported that the needle broke off the bd phaseal¿ protector (p14) and bortezomib leaked out.The following information was provided by the initial reporter, translated from (b)(6): "just when preparing bortezomib the protector broke off".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the needle broke off the bd phaseal¿ protector (p14) and bortezomib leaked out.The following information was provided by the initial reporter, translated from dutch: "just when preparing bortezomib the protector broke off".

Manufacturer Narrative

Investigation summary : three photos were provided to our quality team for investigation.After visual inspection, the needle appears to have penetrated the vial off center.A device history review was performed for reported lot 2107110, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Five retained samples of the same lot were used for additional evaluation.The product was visually inspected and no defects were identified.The products were connected to a vial using the m12 assembly fixture.In all cases, the protector properly penetrated the vial stopper and was correctly fitted onto the vial.Product undergoes a series of inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification the cannula is properly centered, assembled, and there is no damage or other defects on the cannula.No issues related to the reported incident were identified.Based on the quality team's investigation and photo evaluation, it appears this incident occurred during connection.H3 other text : see h10.

• Brand Name: BD PHASEAL¿ PROTECTOR (P14)
• Type of Device: 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 ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14110358
• MDR Text Key: 289257265
• Report Number: 3003152976-2022-00136
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 30382905151003
• UDI-Public: 30382905151003
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K123213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 515100
• Device Catalogue Number: 515100
• Device Lot Number: 2107110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1