MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL PROTECTOR P28; INTRAVASCULAR ADMINISTRATION SET

Model Number	515104
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 leakage occurred between the protector and vial with a bd phaseal¿ protector p28.The following information was provided by the initial reporter: it was reported that a leak occurred between the protector and the vial.Additional information provided 2020-01-16: the investigation team would like to know how the protector was attached to the vial: was it placed manually on the vial or was the phaseal assembly fixture being used? the device was placed manually by the compounding technician.
Additional Manufacturer Narrative
H.6.Investigation: eleven unused protector samples were returned to our quality team for investigation.The product was visually inspected, no damage or defects were identified on any of the products.All samples were functionally tested.The protectors were successfully connected to the vials, ensuring they fit properly.The protectors were then connected to an injector and syringe without issues and no leaks were observed.A device history was performed and found no no-conformance's related to the reported issue during production of batch 1810124.Product undergoes visual and functional testing throughout manufacturing to ensure the quality and functionality of the device, including leakage testing.Test results were reviewed for the reported lot and found to be within specification.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.
Event or Problem Description
It was reported that leakage occurred between the protector and vial with a bd phaseal¿ protector p28.The following information was provided by the initial reporter: it was reported that a leak occurred between the protector and the vial.Additional information provided 2020-01-16: q: - the investigation team would like to know how the protector was attached to the vial: was it placed manually on the vial or was the phaseal assembly fixture being used? a: - the device was placed manually by the compounding technician.

• Brand Name: BD PHASEAL PROTECTOR P28
• 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: 9641029
• Report Number: 3003152976-2020-00019
• Device Sequence Number: 13999406
• Product Code: ONB
• UDI-Device Identifier: 30382905151041
• UDI-Public: 30382905151041
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2020

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 Expiration Date: 09/30/2023
• Device Model Number: 515104
• Device Catalogue Number: 515104
• Device Lot Number: 1810124
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 03/26/2020
• 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