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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD LUER-LOK¿ SYRINGE; PISTON SYRINGE
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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD LUER-LOK¿ SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 303288
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2023
Event Type  malfunction  
Event Description
It was reported that 5 of the bd luer-lok¿ syringe's stopper and plunger detached.The following was received from the initial reporter: while reloading the syringe the stopper and plunger detaches.The practice was same with bd 50ml precise syringes which they were using earlier and there was no issue.As per recode process the bd 50ml precise syringe was replaced by bd plastipak 50ml syringe and they are facing the challenge in bd plastipak 50ml syringes as mentioned above.
 
Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H.6.Investigation summary: one photo which displays the product information was provided to our quality team for investigation.No photos or physical samples that display the reported condition were available for investigation.A device history review was performed for reported lot 2301100, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported issue.The silicone employed in this product is a medial grade and is used during the syringe assembly process to help ease the movement of the plunger.Retained samples of the same lot were used for additional evaluation.The products were visually inspected, no issues were observed and the stopper was verified to be properly assembled onto the plunger rod.Throughout the manufacturing process, break out force, sustaining force testing, and silicone content testing are conducted for each lot to evaluate the movement of the plunger.Results for the reported lot were reviewed and no issues were identified.The retained samples underwent these same evaluations and all product was verified to meet required specifications.Based on our investigation, we are not able to determine a root cause related to the manufacturing process at this time.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.
 
Event Description
It was reported that 5 of the bd luer-lok¿ syringe's stopper and plunger detached.The following was received from the initial reporter: while reloading the syringe the stopper and plunger detaches.The practice was same with bd 50ml precise syringes which they were using earlier and there was no issue.As per recode process the bd 50ml precise syringe was replaced by bd plastipak 50ml syringe and they are facing the challenge in bd plastipak 50ml syringes as mentioned above.
 
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Brand Name
BD LUER-LOK¿ SYRINGE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer (Section G)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga, huesca 22520
SP   22520
Manufacturer Contact
jennifer suh
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key17481451
MDR Text Key320605218
Report Number3002682307-2023-00230
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
NA
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 09/15/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number303288
Device Lot Number2301100
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/15/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/19/2023
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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