MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL OPTIMA PROTECTOR (P20-O MULTI); INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515065
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that bd phaseal optima protector (p20-o multi) leaked.The following information was provided by the initial reporter: "date received for intake: (b)(6) 2020, material no.515065, batch no.2001102.It was reported that after the protector was place on the vial, leak and drop appeared between the protector sleeve and the vial rubber stopper.Per pir: "it was reported that after the protector was place on the vial, leak and drop appeared between the protector sleeve and the vial rubber stopper.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 10/28/2020.H.6.Investigation: upon receipt, the product was indicated to be chemo contaminated and unfortunately, could not be evaluated.One video along photos were also provided to our quality team for investigation.Through visual inspection, a leak around the neck of the bottle was observed.It was noted that the aluminum cap of the vial was damaged and the spike from the protector appeared to be connected at an incline.A device history review was performed for suspected lot 2001102, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Leakage testing is performed for all lots during manufacturing to ensure the quality of the membrane.Results were reviewed for lot 2001102 and no issues related to the reported incident were found.Three retained samples of the same lot were used for additional evaluation.The product was visually inspected and no damage or defects were observed.Each protector was connected to a vial, injector, and syringe.In all cases, the protector properly punctured the vial, the connection was secure, and liquid could be withdrawn from the vial without issue, no leakages occurred.Based on our investigation and sample evaluation, we cannot identify a root cause related to the manufacturing process at this time.
Event or Problem Description
It was reported that bd phaseal optima protector (p20-o multi) leaked.The following information was provided by the initial reporter: "date received for intake: (b)(6) 2020.Material no.515065, batch no.2001102.It was reported that after the protector was place on the vial, leak and drop appeared between the protector sleeve and the vial rubber stopper.Per pir: "it was reported that after the protector was place on the vial, leak and drop appeared between the protector sleeve and the vial rubber stopper.".

• Brand Name: BD PHASEAL OPTIMA PROTECTOR (P20-O MULTI)
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 10767165
• Report Number: 3003152976-2020-00482
• Device Sequence Number: 4246704
• Product Code: ONB
• UDI-Device Identifier: 00382905150654
• UDI-Public: 00382905150654
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2021

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: 01/31/2020
• Device Catalogue Number: 515065
• Device Lot Number: 2001102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Initial Date Received by Manufacturer: 10/08/2020
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 10/31/2020
• Supplement Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1