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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 1ML LL NS; PISTON SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 1ML LL NS; PISTON SYRINGE Back to Search Results
Catalog Number 309648
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/15/2021
Event Type  malfunction  
Event Description
It was reported that 2 bd syringe 1ml ll ns experienced foreign matter in the fluid path.The following information was provided by the initial reporter: while in some syringes droplets of silicone are visible, in others the excess does not become apparent until the plunger is withdrawn (this makes it virtually impossible to inspect out affected syringes).
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 that 2 bd syringe 1ml ll ns experienced foreign matter in the fluid path.The following information was provided by the initial reporter: while in some syringes droplets of silicone are visible, in others the excess does not become apparent until the plunger is withdrawn (this makes it virtually impossible to inspect out affected syringes).
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-12-08 h6: investigation summary fourteen loose 1ml luer lock syringes and two photos displaying a 1ml luer-lock syringe ((b)(6)) were received and evaluated.Each photo showed a zoomed-in view of the syringe where excessive and pooled silicone lubricant was present behind the stopper and in-between its ribs outside of the fluid path.The fourteen loose samples received each contained an excessive amount of lubricant on the barrel exterior and behind the stopper, on the plunger rod, and outside of the fluid path.The observed condition was non-conforming per product specification.This is a known issue for this production batch.Of the complaints received for this batch known potentially impacted boxes are 97-184.The box numbers that the customer currently has in stock are required to determine if the scope expands beyond those just listed.Potential root causes for the excessive silicone defect were determined to be the following: 1.Improper positioning of the silicone gun leading to overspray on barrel flanges and the machine dial.2.Excessive silicone presence due to the misuse of the silicone gun purge function.3.Inadequate capture and confliction in inspection procedures for silicone outside of the fluid path.4.Improper adjustment requirements for silicone purge function.The following corrective actions have been and will be taken in response to this complaint and others received for this batch.Additionally, local exceptions reports were opened to track actions around this complaint.1.The silicone gun will be pinned down at the optimal location to prevent silicone overspray from occurring.Completed: (b)(6) 2021 2.The silicone purge function will no longer be accessible to any operators on the machine.Electronic controls will be put in place to only allow authorized engineers and technicians access to the purge function.Due: (b)(6) 2022 3.The program will be updated to not allow the machine to run while the silicone gun is purging.Due: (b)(6) 2022 4.Update inspection procedures and internal guidebooks to adequately capture this defect.Due: (b)(6) 2022 5.Adjustment procedure for silicone gun purge function will be updated to properly qualify product clean impacted machine areas post purge.Due: (b)(6) 2022.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see h10.
 
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Brand Name
BD SYRINGE 1ML LL NS
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12804350
MDR Text Key285355994
Report Number1213809-2021-00766
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K941562
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309648
Device Lot Number1127514
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/07/2021
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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