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

Model Number	515105
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd phaseal¿ drug vial access device foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: she said there was no leaking, just coring.The customer is finding the ¿coring¿ of the rubber vial upon application of the vial access device the customer believes the coring is worse than normal.
Additional Manufacturer Narrative
H6: investigation summary no samples or photos received for investigation.A device history review was performed for lot 2202123, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Four retained samples from the same lot were evaluated, no issues or coring observed.Fragmentation testing is performed according to procedure, to evaluate any particulates generated by the injector when mated to other components after ten activations.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device, including verification all critical dimensions are within specification and there is no damage on the product.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.It is important to ensure the vial is not expired as that can impact the quality of the rubber stopper.Based on the available information we are not able to identify a definitive root cause at this time.
Event or Problem Description
It was reported while using bd phaseal¿ drug vial access device foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: she said there was no leaking, just coring.The customer is finding the ¿coring¿ of the rubber vial upon application of the vial access device the customer believes the coring is worse than normal.

• 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16592644
• Report Number: 3003152976-2023-00087
• Device Sequence Number: 16867219
• Product Code: ONB
• UDI-Device Identifier: 30382905151058
• UDI-Public: (01)30382905151058
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 04/26/2023

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: 515105
• Device Catalogue Number: 515105
• Device Lot Number: 2202123
• 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: 03/01/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2022
• 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