MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ OPTIMA PROTECTOR (P13-O); INTRAVASCULAR ADMINISTRATION SET

Model Number	515060
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the spike of the bd phaseal¿ optima protector (p13-o) was bent and loose, and the rubber cover of the vial spike was also damaged.The following information was provided by the initial reporter: "the plastic spike is bent and lose and the rubber cover of the vial spike is squished up.They used the m12-o assembly fixture, it is brand new.The medication that they were trying to spike was taxil iv - sandoz brand 5ml vial size.".
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 the spike of the bd phaseal¿ optima protector (p13-o) was bent and loose, and the rubber cover of the vial spike was also damaged.The following information was provided by the initial reporter: "the plastic spike is bent and lose and the rubber cover of the vial spike is squished up.They used the m12-o assembly fixture, it is brand new.The medication that they were trying to spike was taxil iv - sandoz brand 5ml vial size.".
Additional Manufacturer Narrative
Investigation summary one photo was provided to our quality team for investigation.Through visual inspection, the spike appears to be slightly crooked, although it cannot be fully verified as the photo is blurry.There is no visible defects observed within the photo that could indicate why the protector would not insert into the vial.A device history review was performed for lot 2201414, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue retained samples of the same lot were used for additional evaluation.The product was visually inspected and no damage or defects were observed.Functional testing was performed, connecting the protector sample to a vial, injector, and syringe per the instructions for use provided with the product.In all cases the protector was properly fitted to the vial, liquid was able to be drawn from the vial, and the product functioned as intended.Product is visually and functionally tested throughout manufacturing according to procedure, ensuring the quality and functionality of the device, including verification that all critical dimensions are within specification, no issues related to the reported issue were noted.Based on our investigation we cannot identify a root cause related to our manufacturing process at this time.

• Brand Name: BD PHASEAL¿ OPTIMA PROTECTOR (P13-O)
• 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 ; 8015296192
• MDR Report Key: 16375220
• Report Number: 3003152976-2023-00024
• Device Sequence Number: 15339498
• Product Code: ONB
• UDI-Device Identifier: 00382905150609
• UDI-Public: 00382905150609
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K181221
• 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): 03/08/2023

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 Expiration Date: 12/31/2023
• Device Model Number: 515060
• Device Catalogue Number: 515060
• Device Lot Number: 2201414
• 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: 01/24/2023
• Supplement Date Received by Manufacturer: 03/08/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 03/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2022
• 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