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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH SF SALINE FLUSH 10ML; SALINE, VASCULAR ACCESS FLUSH
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BECTON, DICKINSON AND CO. BD POSIFLUSH SF SALINE FLUSH 10ML; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Model Number 306553
Device Problems Leak/Splash (1354); Failure to Deliver (2338)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/21/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Initial reporter state: address information was not able to be obtained.(b)(6) was used as a place holder.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
 
Event Description
It was reported that during use with a bd posiflush¿ sf saline flush 10ml the plunger was difficult to move.The following information was provided by the initial reporter: it was reported that it was difficult to flush and draw back when using the syringe with the extension tube set.The customer suspected that it was not always being caught by the nurse placing the line as they suspect the vein was bad as opposed to the extension tubing being the source of the problem with the patency.Actual sample was available for evaluation.Patient involvement was unknown.
 
Event Description
It was reported that during use with a bd posiflush¿ sf saline flush 10ml the plunger was difficult to move.The following information was provided by the initial reporter: it was reported that it was difficult to flush and draw back when using the syringe with the extension tube set.The customer suspected that it was not always being caught by the nurse placing the line as they suspect the vein was bad as opposed to the extension tubing being the source of the problem with the patency.Actual sample was available for evaluation.Patient involvement was unknown.
 
Manufacturer Narrative
H.6.Investigation: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.The complaint could not be confirmed and the root cause is undetermined.Dhr could not be performed due to unknown lot#.
 
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Brand Name
BD POSIFLUSH SF SALINE FLUSH 10ML
Type of Device
SALINE, VASCULAR ACCESS FLUSH
Manufacturer (Section D)
BECTON, DICKINSON AND CO.
donore road
drogheda
MDR Report Key10525489
MDR Text Key216396429
Report Number9616657-2020-00143
Device Sequence Number1
Product Code NGT
UDI-Device Identifier30382903065531
UDI-Public30382903065531
Combination Product (y/n)N
PMA/PMN Number
K153481
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 09/23/2020
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 Model Number306553
Device Catalogue Number306553
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/21/2020
Initial Date FDA Received09/11/2020
Supplement Dates Manufacturer Received08/21/2020
Supplement Dates FDA Received09/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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