Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 N35J
  • 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 N35J Back to Search Results
Catalog Number 515008
Device Problem Difficult or Delayed Activation (2577)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/20/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that bd phaseal¿ injector luer lock n35j needle was exposed.This was discovered during use.The following information was provided by the initial reporter: after giving cisplatin to the patient by syringe, the needle was exposed when removing from the connector.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes d.10.Returned to manufacturer on: 2/28/2020 h.6.Investigation: one sample was provided to our quality team for investigation.Upon visually inspecting the product, no issues or damage was observed on the injector.Functional evaluations were performed and the injector was able to properly connect to a connector without issue.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.As the lot involved in this incident is unknown, a device history review could not be performed.Based on our investigation we were not able to identify a root cause related to our manufacturing process at this time.
 
Event Description
It was reported that bd phaseal¿ injector luer lock n35j needle was exposed.This was discovered during use.The following information was provided by the initial reporter: after giving cisplatin to the patient by syringe, the needle was exposed when removing from the connector.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD PHASEAL INJECTOR LUER LOCK N35J
Type of Device
INJECTOR
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key9819033
MDR Text Key210002036
Report Number3003152976-2020-00119
Device Sequence Number1
Product Code LHI
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 04/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number515008
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/28/2020
Initial Date Manufacturer Received 02/20/2020
Initial Date FDA Received03/11/2020
Supplement Dates Manufacturer Received02/20/2020
Supplement Dates FDA Received04/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-