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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH; SALINE VASCULAR ACCESS FLUSH

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BECTON, DICKINSON AND CO. BD POSIFLUSH; SALINE VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306572
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/05/2024
Event Type  malfunction  
Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.B3.The date received by manufacturer has been used for this field.
 
Event Description
It was reported that bd posiflush 10ml plunger pulled out of the stopper during aspiration.The following information was provided by the initial reporter, translated from french to english: when using pre-filled syringes for cvc, we do use the syringe with the plunger already pulled out, but we first purge the connections with this syringe before attaching them to the patient's cvc (central catheter).Once the connectors have been attached to the cvc, we draw saline; blood into the syringe pump barrel to eliminate any air bubbles that may be present in the cvc branches, then return the blood; saline under pulsed pressure.The defect was detected when the blood; saline was aspirated before being reinjected into the patient.The black rubber actually dislodged from the plunger when i pulled on my syringe, but remained in the syringe pump body, preventing leakage of nacl liquid as well as blood.Additional information: patient risk: possible risk of contaminating the inside of the syringe or injecting air.
 
Event Description
No additional information.
 
Manufacturer Narrative
As no physical sample, valid lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.H3 other text : see narrative below.
 
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Brand Name
BD POSIFLUSH
Type of Device
SALINE VASCULAR ACCESS FLUSH
Manufacturer (Section D)
BECTON, DICKINSON AND CO.
donore road
drogheda
Manufacturer (Section G)
BECTON, DICKINSON AND CO.
donore road
drogheda
Manufacturer Contact
helen cox (mdr)
75 north fairway drive
vernon hills, IL 60061
8473935694
MDR Report Key18990913
MDR Text Key339257207
Report Number9616657-2024-00012
Device Sequence Number1
Product Code NGT
UDI-Device Identifier00382903065721
UDI-Public(01)00382903065721
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/09/2024
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 Number306572
Device Lot NumberUNKNOWN
Initial Date Manufacturer Received 03/05/2024
Initial Date FDA Received03/28/2024
Supplement Dates Manufacturer Received04/09/2024
Supplement Dates FDA Received04/15/2024
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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