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

Model Number	515117
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
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 that during use with bd phaseal¿ protector p55 coring occurred.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this report is about coring the rubber stopper for a vial.When the protector was attached to the vial to prepare endoxan, coring "occurred".The rubber piece was mixed inside.
Event or Problem Description
It was reported that during use with bd phaseal¿ protector p55 coring occurred.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: this report is about coring the rubber stopper for a vial.When the protector was attached to the vial to prepare endoxan, coring ocurred.The rubber piece was mixed inside.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 13-jun-2023.H.6.Investigation summary: one protector connected to a vial was provided to our quality team for investigation.The product was visually inspected, the protector penetrated the vial stopper properly, however, it was noted the spike of the protector was bent and a particle was observed within the vial.Characterization testing was performed and found the particle was consistent with material from the rubber stopper of the vial.It cannot be determined whether the spike tip was bent before use or during the connection of the device.A device history review was performed for lot 2205106, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported incident.Fragmentation testing is performed during manufacturing to evaluate any particulates generated after ten activations.While phaseal needles are designed to reduce coring, there are several factors that may impact coring tendency.Coring from the membrane may occur due to fragmentation caused by multiple injections or excessive welding of the membrane.Coring of the rubber stopper may result depending on the stopper quality, the design and dimensions of the needles used, or if a poor connection of the protector occurs.Based on the available information we are not able to identify a definitive root cause at this time.The m12 assembly fixture is recommended to ease the connection of the protector to the vial.Complaints received for this device and reported condition will continue to be tracked and trended for future occurrence.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17202113
• Report Number: 3003152976-2023-00249
• Device Sequence Number: 6666734
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2023

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: 2205106
• 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: 06/01/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2022
• 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