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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 5ML SALINE FILL CHINA SP; SALINE, VASCULAR ACCESS FLUSH
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BECTON DICKINSON SYRINGE 5ML SALINE FILL CHINA SP; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306594
Device Problem Fracture (1260)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/06/2024
Event Type  malfunction  
Event Description
The nurse found a crack in the syringe of the prefilled catheter irrigator when sealing the patient's indwelling needle and replaced it.
 
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.H3 other text : see h10 manufacture narrative.
 
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Brand Name
SYRINGE 5ML 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 Key18886457
MDR Text Key337447223
Report Number1911916-2024-00178
Device Sequence Number1
Product Code NGT
UDI-Device Identifier30382903065944
UDI-Public(01)30382903065944
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K161552
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
Report Date 03/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number306594
Device Lot Number3206750
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/08/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/25/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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