MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 22X1 RB; PISTON SYRINGE

Catalog Number	309572
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that syringe 3ml ll w/ndl 22x1 rb had liquid inside.This occurred on 2 occasions.The following information was provided by the initial reporter: it was reported that syringes had a liquid in them before drawing up medication.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-11-08.H6: investigation summary two loose 3ml syringes with needles (b)(4) were received.The samples were visually evaluated.Upon exercising the plunger/stopper assembly liquid was observed to be stringing between the barrel roof and stopper.Some pooling was evident on the stopper as well.The liquid appeared to be silicone lubricant, of which there was an excessive amount present.The observed condition was non-conforming per product specification.Potential root cause for the excessive silicone defect is associated with the assembly process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batch #9304828 is considered in compliance with our product specification requirements.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.
Event or Problem Description
It was reported that syringe 3ml ll w/ndl 22x1 rb had liquid inside.This occurred on 2 occasions.The following information was provided by the initial reporter: it was reported that syringes had a liquid in them before drawing up medication.

• Brand Name: SYRINGE 3ML LL W/NDL 22X1 RB
• Common Device Name: 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 Key: 12689684
• Report Number: 1213809-2021-00722
• Device Sequence Number: 17184907
• Product Code: FMF
• UDI-Device Identifier: 00382903095728
• UDI-Public: 00382903095728
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2021

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
• Operator of Device: Other
• Device Expiration Date: 09/30/2024
• Device Catalogue Number: 309572
• Device Lot Number: 9304828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 11/16/2021
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown