MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PROTECTOR P20-O MULTIPACK; INTRAVASCULAR ADMINISTRATION SET

Model Number	515065
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Address information was not able to be obtained, therefore, (b)(6) was used as a place holder.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 protector p20-o multipack the rubber stopper was pushed into the vial.There was no report of patient impact.The following information was provided by the initial reporter: when putting optima p20 protector onto the rituxan vial in the hood in pharmacy, the rubber stopper caved into the vial.
Event or Problem Description
It was reported while using bd protector p20-o multipack the rubber stopper was pushed into the vial.There was no report of patient impact.The following information was provided by the initial reporter: when putting optima p20 protector onto the rituxan vial in the hood in pharmacy, the rubber stopper caved into the vial.
Additional Manufacturer Narrative
H6: investigation summary: no physical samples were provided to our quality team for investigation.Three photos were provided which display the protector and vial inside a plastic bag.There is no damage or other defects that can be identified within the photo.A device history review was performed for lot 2203406, 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 damage or defects were observed and all dimensional evaluations verified the product was within specifications.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 PROTECTOR P20-O MULTIPACK
• 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: 15782769
• Report Number: 3003152976-2022-00507
• Device Sequence Number: 20518461
• Product Code: ONB
• UDI-Device Identifier: 00382905150654
• UDI-Public: (01)00382905150654
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2023

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: 02/29/2024
• Device Model Number: 515065
• Device Catalogue Number: 515065
• Device Lot Number: 2203406
• 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: 10/18/2022
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 11/11/2022
• Supplement Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2022
• 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