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

Catalog Number	515105
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported while using bd phaseal¿ drug vial access device coring occurred.There was no report of patient impact.The following information was provided by the initial reporter: when compounding it's been newly noticed that there is definite coring happening when using the protector code 515105 lot 2207114.And injector 515003 lot 2212001.Penetration of the membranes are at most 5 times.This is a new issue, have not happened in previous sessions.Started using phaseal in compounding from the (b)(6) 2023.
Additional Manufacturer Narrative
Pr (b)(4) follow up emdr for device evaluation protector p50: photos that display the material information were provided, however, no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for protector lot 2207114 and injector lot 2212001, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Fragmentation testing is performed according to procedure, to evaluate any particulates generated by the injector when mated to other components after ten activations.Results were review for the reported lots and found to be within specification.Retained samples of lot 2207114 and 2212001 were used for additional evaluation.The product was visually inspected, no defects were identified.Fragmentation was also performed, connecting a sample injector and penetrating each protector ten times.In all cases no issues were observed, all product met required specifications.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.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.H3 other text : see manufacturer narrative.
Event or Problem Description
When compounding it's been newly noticed that there is definite coring happening when using the protector code 515105 lot 2207114.And injector 515003 lot 2212001.Penetration of the membranes are at most 5 times.This is a new issue, have not happened in previous sessions.Started using phaseal in compounding from the 17th of july 2023.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17691934
• Report Number: 3003152976-2023-00372
• Device Sequence Number: 15085958
• Product Code: ONB
• UDI-Device Identifier: 00382905151057
• UDI-Public: (01)00382905151057
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

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: 515105
• Device Lot Number: 2207114
• 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: 08/21/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• 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