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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGES,; SALINE, VASCULAR ACCESS FLUSH
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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGES,; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Catalog Number 306546
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/20/2023
Event Type  malfunction  
Event Description
It was reported while using bd posiflush¿ normal saline syringes, leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: incident details: was flushing patient's lumen and blood bypassed the rubber plunger and sprayed back at me.Impact of incident: no harm to patient.Unexpected or prolonged care? no.
 
Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
Device available for eval?: yes.D.9.Returned to manufacturer on: 19-oct-2023.H.6.Investigation summary: it was reported blood bypassed the rubber plunger.To aid in the investigation, one empty sample was received with no packaging flow wrap or tip cap.A visual inspection was performed, and no defects or imperfections were observed.The sample was then tested for leakage past the stopper and passed.It could be possible the customer is not using the unit as intended.This product is designed to expel the solution by pressing the plunger rod down, then dispose of the syringe.It is not designed to pull the plunger rod back.A device history record review was completed for provided material number 306546, lot 3142731.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported while using bd posiflush¿ normal saline syringes, leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: incident details: was flushing patient's lumen and blood bypassed the rubber plunger and sprayed back at me.Impact of incident: no harm to patient.Unexpected or prolonged care? no.
 
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Brand Name
BD POSIFLUSH¿ NORMAL SALINE SYRINGES,
Type of Device
SALINE, VASCULAR ACCESS FLUSH
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer (Section G)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer Contact
jennifer suh
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key17873723
MDR Text Key325347345
Report Number1911916-2023-00735
Device Sequence Number1
Product Code NGT
UDI-Device Identifier30382903065463
UDI-Public(01)30382903065463
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K003553
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number306546
Device Lot Number3142731
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/24/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/22/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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