• 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 SYRINGE 10ML SALINE FILL CHINA SP; SALINE, VASCULAR ACCESS FLUSH

  • 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 SYRINGE 10ML SALINE FILL CHINA SP; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306595
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/20/2024
Event Type  malfunction  
Manufacturer Narrative
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
 
Event Description
"purpose of use: intravenous tube flushing before infusion basis for use:intravenous flushing before infusion port use condition of use:bd pre-flush catheter flushing syringe with cracked wall and fluid leakage adverse event condition:cracked pre-flush syringe impact on victims:possible contamination of the fluid in the pre-flush, use may result in infection of the tubing or body treatment action taken:(b)(6) 2024.Treatment taken:replacement of a pre-flush syringe with a new one time to improvement of adverse event:(b)(6) 2024".
 
Manufacturer Narrative
Pr (b)(4) follow up.A device history record review was completed by our quality engineer team for provided material number 306595 and lot number 3142709.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.
 
Event Description
No additional information received "purpose of use: intravenous tube flushing before infusion basis for use:intravenous flushing before infusion port use condition of use:bd pre-flush catheter flushing syringe with cracked wall and fluid leakage adverse event condition:cracked pre-flush syringe impact on victims:possible contamination of the fluid in the pre-flush, use may result in infection of the tubing or body treatment action taken: (b)(4) 2024 treatment taken:replacement of a pre-flush syringe with a new one time to improvement of adverse event: 2024-01-20".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SYRINGE 10ML SALINE FILL CHINA SP
Type of Device
SALINE, VASCULAR ACCESS FLUSH
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer Contact
helen cox (mdr)
75 north fairway drive
vernon hills, IL 60061
8473935694
MDR Report Key18677414
MDR Text Key336304510
Report Number1911916-2024-00073
Device Sequence Number1
Product Code NGT
UDI-Device Identifier30382903065951
UDI-Public(01)30382903065951
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K003553
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/05/2024
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
Device Operator Health Professional
Device Catalogue Number306595
Device Lot Number3142709
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/07/2024
Initial Date FDA Received02/09/2024
Supplement Dates Manufacturer Received03/05/2024
Supplement Dates FDA Received03/06/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/22/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
-
-