• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P50J ADMINISTRATION SET

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P50J ADMINISTRATION SET Back to Search Results
Catalog Number 515111
Device Problems Detachment Of Device Component (1104); Needle (3088)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/11/2018
Event Type  Malfunction  
Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.

 
Event Description

It was reported that during use, a bd phaseal¿ protector p50j malfunctioned as the needle separated. They ¿disconnected the n35j and the p50j, but the needle of p50j remained in the rubber stopper of the vial. ¿ there was no report of injury or medical intervention reported.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD PHASEAL¿ PROTECTOR P50J
Type of DeviceADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7245471
MDR Text Key99329946
Report Number3003152976-2018-00016
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberN/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,OTHER,USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/28/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number515111
Device LOT Number1702026
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/12/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/29/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/06/2018 Patient Sequence Number: 1
-
-