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

Catalog Number	515060
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Initial reporter phone #: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that there was flow issues where the injector appear to be drawing medication back into the vial with a bd phaseal optima protector (p13-o).The following information was provided by the company reporter: (3 of 4 complaints) it was reported that the medication was having trouble flowing completely into the vial with one injection.The following information was provided by the initial reporter: we are noticing that the injectors seem to be pulling drug back into the vial after we have detached the syringe with the amount we had needed causing us to have to back into the vial a few times to get the desired amount to stay.
Additional Manufacturer Narrative
H.6.Investigation summary: two samples from protector lot 1901101 were returned to our quality team for investigation.The product was visually inspected with no defects observed.The samples were functionally tested, connecting a sample injector to the protectors along with the vial and a syringe according to the instructions for use.In all cases it was possible to withdraw fluid from the vial, the expansion chamber functioned properly, and the product functioned as intended.A device history review was performed for reported lot 1901101, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Product undergoes a series of inspections throughout the manufacturing process to ensure the quality and functionality of the device, including flow rate verification.Testing results for lot 1901101, along with the testing performed on the received samples were reviewed, no defects were observed and product met required specifications.Based on the available information we are not able to identify a root cause at this time.Complaints received for this defect and device will continue to be monitored by our quality team for signs of emerging trends.H3 other text : see section h.10.
Event or Problem Description
It was reported that there was flow issues where the injector appear to be drawing medication back into the vial with a bd phaseal optima protector (p13-o).The following information was provided by the company reporter: (3 of 4 complaints) it was reported that the medication was having trouble flowing completely into the vial with one injection.The following information was provided by the initial reporter: we are noticing that the injectors seem to be pulling drug back into the vial after we have detached the syringe with the amount we had needed causing us to have to back into the vial a few times to get the desired amount to stay.

• 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
• MDR Report Key: 9174894
• Report Number: 3003152976-2019-00712
• Device Sequence Number: 2242822
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 515060
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 11/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other