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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNKNOW SALINE FLUSH; SALINE, VASCULAR ACCESS FLUSH
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BECTON DICKINSON UNKNOW SALINE FLUSH; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number UNKNOWN
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/06/2024
Event Type  malfunction  
Event Description
On (b)(6), during routine picc flushing for a child at night, water leaked from the front connector of the nipple connection of the syringe.It was replaced immediately without causing harm to the patient.
 
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
UNKNOW SALINE FLUSH
Type of Device
SALINE, VASCULAR ACCESS FLUSH
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BD MDS DCHU
75 north fairway drive
vernon hills IL 60061
Manufacturer Contact
helen cox (mdr)
75 north fairway drive
vernon hills, IL 60061
8473935694
MDR Report Key18570261
MDR Text Key333557808
Report Number2243072-2024-00058
Device Sequence Number1
Product Code NGT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
UNK
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 01/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/24/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot Number2066680
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/11/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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