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U.S. Department of Health and Human Services

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

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BECTON, DICKINSON AND CO. BD FLUSH EXT STERILE; SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Model Number 306553
Device Problem Missing Information (4053)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/20/2023
Event Type  malfunction  
Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported there were 3 bd flush ext sterile syringe's missing all print.The following information was provided by the initial reporter: verbatim: it is reported that a number of messages about syringes (306553) missing all print.
 
Event Description
It was reported there were 3 bd flush ext sterile syringe's missing all print.The following information was provided by the initial reporter: verbatim: it is reported that a number of messages about syringes (306553) missing all print.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 21-jul-2023.Investigation summary a device history record review was completed for provided material number 306553 and lot number 3026599.The review did not find any detected non-conformances during the production process that could have contributed to this incident.To aid in the investigation of this issue, two (2) picture samples and three (3) physical samples were returned for evaluation by our quality engineer team.Through inspection of the samples, two (2) syringes were found to be missing the barrel label.The third syringe had two (2) barrel labels applied.This incident most likely resulted from a jam in the plunger rod labeler, which was not cleared.After the jam, the defective syringes were not rejected by the vision system at the plunger rod station.An additional control has been initiated, with the installation of a sensor further downstream to inspect 100% of syringes for barrel label presence.
 
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Brand Name
BD FLUSH EXT STERILE
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
phillip emmert
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key17321658
MDR Text Key319252178
Report Number9616657-2023-00023
Device Sequence Number1
Product Code NGT
UDI-Device Identifier30382903065531
UDI-Public(01)30382903065531
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K153481
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 08/14/2023
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 Model Number306553
Device Catalogue Number306553
Device Lot Number3026599
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/21/2023
Initial Date FDA Received07/13/2023
Supplement Dates Manufacturer Received08/14/2023
Supplement Dates FDA Received08/30/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/26/2023
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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