MAUDE Adverse Event Report: BECTON DICKINSON, S.A. PROTECTOR P21; PHASEAL PROTECTOR

Catalog Number	515102
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: 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.(b)(4).
Event or Problem Description
It was reported that an unspecified number of protector p21 experienced needle separation on the protector during use.The following information was provided by the initial reporter: when taking of the injector from the protector , the protector white part came also of the vial and the needle stayed in site.
Additional Manufacturer Narrative
H.6.Investigation: one photo was provided to our quality team for investigation.Through visual inspection, the photo displays the protector separated from the vial and the needle is observed to be detached.There was no visible damage or defects identified on the protector.As lot information for this incident was not available, a device history review could not be performed.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.H3 other text : see h.10.
Event or Problem Description
It was reported that an unspecified number of protector p21 experienced needle separation on the protector during use.The following information was provided by the initial reporter: when taking of the injector from the protector , the protector white part came also of the vial and the needle stayed insite.

• Brand Name: PROTECTOR P21
• Common Device Name: PHASEAL PROTECTOR
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 10687584
• Report Number: 3003152976-2020-00450
• Device Sequence Number: 3188614
• Product Code: LHI
• UDI-Device Identifier: 00382905151026
• UDI-Public: 00382905151026
• 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): 11/03/2020

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 Catalogue Number: 515102
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 10/15/2020
• Supplement Report FDA Received Date: 11/03/2020
• 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