MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL PROTECTOR P21; INTRAVASCULAR ADMINISTRATION SET

Model Number	515102
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address: (b)(6).Medical device expiration date: unknown, device manufacture date: unknown.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 that a bd phaseal protector p21 leaked between the protector and the vial.The following information was provided by the initial reporter: "leakage between protector and vial when they prepared antibiotics.No patient involved.".
Additional Manufacturer Narrative
H.6.Investigation: one sample was returned to our quality team for investigation.The product was visually inspected, no defects or damage observed on the protectors and the protectors fit securely to the vial.Functional testing was performed, connecting a sample syringe and injector to the protector, liquid inside the syringe could move to the vial and back to the syringe without issue and no leaks were observed.Leakage testing is performed for all lots during manufacturing to ensure the quality of the membrane.As lot information for this incident was not available, a device history review could not be performed.Based on the available we are not able to identify a root cause at this time.
Event or Problem Description
It was reported that a bd phaseal protector p21 leaked between the protector and the vial.The following information was provided by the initial reporter: "leakage between protector and vial when they prepared antibiotics.No patient involved.".

• Brand Name: BD PHASEAL PROTECTOR P21
• 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: 9795526
• Report Number: 3003152976-2020-00102
• Device Sequence Number: 16724595
• Product Code: ONB
• UDI-Device Identifier: 30382905151027
• UDI-Public: 30382905151027
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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 Model Number: 515102
• Device Catalogue Number: 515102
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/13/2020
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 03/05/2020
• Supplement Report FDA Received Date: 04/14/2020
• 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