MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE; PISTON SYRINGE

Model Number	309589
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	03/21/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the bd luer-lok¿ syringe with attached needle experienced foreign matter in the fluid path.The following information was provided by the initial reporter: particle contaminant on sterile needle.
Additional Manufacturer Narrative
H.6.Investigation: it was reported that particle contaminant on the sterile needle.To aid in the investigation, one photo was received for evaluation by our quality teams.Through visual inspection, one piece of white particulate foreign matter was observed.The conditions observed at the packaging site were non-conforming per product specification.The photo was sent to the needle manufacturing site for further evaluation and investigation.At the needle manufacturing site, one photo was received.A visual inspection was performed and observed that epoxy drip over on the needle.It is possible that a jam may have occurred at the cannulator inducing the white epoxy drip over on the needle.Verification of the cannulator was performed.The settings were correct and the flow of products was good.A device history record review was completed for provided lot number 0253053.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.Based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.
Event or Problem Description
It was reported that the bd luer-lok¿ syringe with attached needle experienced foreign matter in the fluid path.The following information was provided by the initial reporter: particle contaminant on sterile needle.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14120458
• Report Number: 1213809-2022-00191
• Device Sequence Number: 14536764
• Product Code: FMF
• UDI-Device Identifier: 30382903095897
• UDI-Public: 30382903095897
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2022

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: 08/31/2025
• Device Model Number: 309589
• Device Catalogue Number: 309589
• Device Lot Number: 0253053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 05/30/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 06/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2020
• 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