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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE; VASCULAR ACCESS FLUSH

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BECTON, DICKINSON AND CO. 10 ML BD POSIFLUSH NORMAL SALINE SYRINGE; VASCULAR ACCESS FLUSH Back to Search Results
Model Number 306546
Device Problems Leak/Splash (1354); Failure to Deliver (2338)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/27/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that 10 ml bd posiflush¿ normal saline syringe plunger rod got stuck on 7 occasions during use.The following information was provided by the initial reporter: material no.306546 batch no.0126434 it was reported that as the line is being flushed, the plunger rod will get stuck leaving approximately 2ml's remaining in the syringe.
 
Manufacturer Narrative
H.6.Investigation: a device history record review was performed for provided lot number (b)(4) and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.As neither a physical sample nor a picture sample was available for return, our quality team was unable to complete a thorough sample investigation.Based on the investigation results, a cause related to the manufacturing process could not be determined for this incident.Our quality team will closely monitor the production process for signs of this potential defect and any emerging trends.
 
Event Description
It was reported that 10 ml bd posiflush¿ normal saline syringe plunger rod got stuck on 7 occasions during use.The following information was provided by the initial reporter: material no.(b)(4) batch no.0126434 it was reported that as the line is being flushed, the plunger rod will get stuck leaving approximately 2ml's remaining in the syringe.
 
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Brand Name
10 ML BD POSIFLUSH NORMAL SALINE SYRINGE
Type of Device
VASCULAR ACCESS FLUSH
Manufacturer (Section D)
BECTON, DICKINSON AND CO.
donore road
drogheda
MDR Report Key10551547
MDR Text Key208758636
Report Number9616657-2020-00153
Device Sequence Number1
Product Code NGT
UDI-Device Identifier30382903065463
UDI-Public30382903065463
Combination Product (y/n)N
PMA/PMN Number
K141311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 09/29/2020
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 Other
Device Expiration Date04/30/2023
Device Model Number306546
Device Catalogue Number306546
Device Lot Number0126434
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/27/2020
Initial Date FDA Received09/17/2020
Supplement Dates Manufacturer Received08/27/2020
Supplement Dates FDA Received09/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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