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

Model Number	515102
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.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 protector p21 had foreign matter.The following information was provided by the initial reporter: after capping the vial, hair found in the balloon.Has clearly ended up there during production.The protector was already attached to a vial of kadcyla 100 mg ((b)(6)) so it could no longer be used.
Additional Manufacturer Narrative
H.6.Investigation: one photo was provided to our quality team for investigation.Through visual inspection, a hair was observed between the expansion bladder and film.Retained samples of lot 2007145 were used for additional evaluation.All product was inspected, no hair or other foreign matter was observed.A device history review was performed for the reported lot 2007145, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.While we could not identify a direct issue, the root cause of this incident is due to personnel not following the proper gowning procedure.
Event or Problem Description
It was reported that protector p21 had foreign matter.The following information was provided by the initial reporter: after capping the vial, hair found in the balloon.Has clearly ended up there during production.The protector was already attached to a vial of kadcyla 100 mg (¿1645) so it could no longer be used.

• Brand Name: 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: 11263456
• Report Number: 3003152976-2021-00057
• Device Sequence Number: 1219209
• Product Code: ONB
• UDI-Device Identifier: 30382905151027
• UDI-Public: 30382905151027
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 02/23/2021

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: 06/30/2025
• Device Model Number: 515102
• Device Catalogue Number: 515102
• Device Lot Number: 2007145
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 02/01/2021
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1