• 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¿ INJECTOR LUER LOCK (N35C) INTRAVASCULAR 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¿ INJECTOR LUER LOCK (N35C) INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 515005
Device Problem Failure to Advance (2524)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/16/2017
Event Type  malfunction  
Manufacturer Narrative
The pictures in jfrl report show the needle exposed and the injector still active while it is being disengaged. The pictures also shows the grips of the safety sleeve out of place. This is a consequence of having turning the injector while connection. Device history record cannot be reviewed as the lot is unknown. The investigation concluded: bd was able to confirm the customer¿s indicated failure visual inspections for injector parts (cylinder, needle housing, safety sleeve, piston and membrane) are performed by the operator to avoid faulty parts (flashes, unfilled and burned parts, etc). Conclusion: the needle has been exposed. This takes place as the injector is still active while disconnection. The grips are out of place and the piston a little damaged. This is a consequence of having turning the injector while connection. Taking into account the jfrl report and the description of the complaint, it seems that the most possible root cause is a bad handling of the device.
 
Manufacturer Narrative
Medical device lot #: unknown. Medical 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.
 
Event Description
It was reported during use of the bd phaseal¿ injector luer lock when the health care professional connected the spike set, she couldn't advance the needle. She continued pushing and needle was then exposed. There was no report of injury or medical intervention.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD PHASEAL¿ INJECTOR LUER LOCK (N35C)
Type of DeviceINTRAVASCULAR ADMINISTRATION 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 Key7011136
MDR Text Key253232487
Report Number3003152976-2017-00108
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K123213
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 12/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number515005
Device Lot NumberUNKNOWN
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 Received10/16/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 11/08/2017 Patient Sequence Number: 1
-
-