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 Consequences Or Impact To Patient (2199)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter email: two additional email addresses were provided as (b)(6) and (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that an unspecified number of bd phaseal¿ protector p21 experienced leakage during use.The following information was provided by the initial reporter: on july 22, under a laminar flow hood, a p21 protector (phaseal bd) was used on a carmustine bottle, it was reconstituted with absolute alcohol plus double-distilled water, at the time of extracting the reconstituted drug, much of it went to the bag that contains the protector (vapor space), so a lot of drug was lost.The loss was not important since what was left was enough for the dose required for the patient.There was no adverse event or harm to the patient or preparer.
Event or Problem Description
It was reported that an unspecified number of bd phaseal¿ protector p21 experienced liquid in the expansion chamber during use.The following information was provided by the initial reporter: on (b)(6), under a laminar flow hood, a p21 protector (phaseal bd) was used on a carmustine bottle, it was reconstituted with absolute alcohol plus double-distilled water, at the time of extracting the reconstituted drug, much of it went to the bag that contains the protector (vapor space), so a lot of drug was lost.The loss was not important since what was left was enough for the dose required for the patient.There was no adverse event or harm to the patient or preparer.
Additional Manufacturer Narrative
The following information has been corrected: b.3.Describe event or problem: it was reported that an unspecified number of bd phaseal¿ protector p21 experienced liquid in the expansion chamber during use.The following information was provided by the initial reporter: on july 22, under a laminar flow hood, a p21 protector (phaseal bd) was used on a carmustine bottle, it was reconstituted with absolute alcohol plus double-distilled water, at the time of extracting the reconstituted drug, much of it went to the bag that contains the protector (vapor space), so a lot of drug was lost.The loss was not important since what was left was enough for the dose required for the patient.There was no adverse event or harm to the patient or preparer.This incident is unlikely to lead to harm/serious injury, therefore this incident is not considered reportable.

• 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: 10411622
• Report Number: 3003152976-2020-00364
• Device Sequence Number: 2391786
• Product Code: ONB
• UDI-Device Identifier: 30382905151027
• UDI-Public: 30382905151027
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 09/04/2020

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: 10/31/2024
• Device Model Number: 515102
• Device Catalogue Number: 515102
• Device Lot Number: 1911105
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/14/2020
• Supplement Report FDA Received Date: 09/07/2020
• 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