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U.S. Department of Health and Human Services

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

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BECTON, DICKINSON AND CO. BD HYPO- POSIFLUSH SYRINGE 10ML; 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 02/23/2024
Event Type  malfunction  
Event Description
It was reported that bd hypo- posiflush syringe 10ml leaked within the unit package.The following information was provided by the initial reporter: the complaint i got was ¿ there have been a handful of the 10 ml saline flushes that are leaking into their packaging¿.I¿m not sure if the every leaking flush is from the same container or lots, nursing sent them to pharmacy instead of back to us.The one i have in front of me is lot # 3250016!.
 
Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
 
Manufacturer Narrative
A device history record review was completed for provided material number 306546 and lot number 3250016.The review did not reveal any possible non-conformances during the production process that could have contributed to the reported incident.To aid in the investigation of this issue, the affected physical sample was returned for evaluation by our quality team.The syringe sample was still within the original unopened packaging.Through analysis of the sample, the stopper component was found out of proper position.Through the investigation results, the most probable cause for the leaking syringe was the stopper being out of position and/or a loose tip cap.However, there were no non-conformances identified during the production process.As this is the first report received for this type of defect on material number 306546 and lot number 3250016, further action has not been determined necessary at this time.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.
 
Event Description
No additional information.
 
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Brand Name
BD HYPO- POSIFLUSH SYRINGE 10ML
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 Key18918074
MDR Text Key337857710
Report Number9616657-2024-00010
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903065463
UDI-Public(01)30382903065463
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003553
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/12/2024
2 Devices were Involved in the Event: 1   2  
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 Catalogue Number306546
Device Lot Number3250016
Initial Date Manufacturer Received 02/23/2024
Initial Date FDA Received03/15/2024
Supplement Dates Manufacturer Received04/12/2024
Supplement Dates FDA Received04/12/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/07/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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