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

Catalog Number	309571
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.E.1.The customer's address is unknown.Virginia, usa has been used as a placeholder based on the reported phone area code.H.3.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 3 bd luer-lok¿ syringes with attached needle had no lot/expiration date on their labeling.The following information was provided by the initial reporter: "we have received and discovered an additional three cases that did not have the secondary barcode along with the lot/expiration date on the label.".
Additional Manufacturer Narrative
H6: investigation summary: one photo of a 3ml luer-lock syringe box carton was received and evaluated.The image shows two box cartons, both having box labels on the carton with one label having all applicable product information and the other label missing the secondary bar code, batch number and expiration date.The condition observed is non-conforming per product specification.Potential root cause for the label content missing defect is associated with the packaging process.As corrective actions, quality alert will be issued to manufacturing facility and re-education will be provided to all operators associated with production batch.A device history record review showed no rejected inspections or quality issues during the production of the provided batch number that could have contributed to the reported defect.
Event or Problem Description
It was reported that 3 bd luer-lok¿ syringes with attached needle had no lot/expiration date on their labeling.The following information was provided by the initial reporter: "we have received and discovered an additional three cases that did not have the secondary barcode along with the lot/expiration date on the label.".

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17795517
• Report Number: 1213809-2023-01054
• Device Sequence Number: 6717115
• Product Code: FMF
• UDI-Device Identifier: 30382903095712
• UDI-Public: 30382903095712
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• 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): 10/12/2023

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 Catalogue Number: 309571
• Device Lot Number: UNKNOWN
• 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: 09/06/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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