MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ 3ML W/NDL; PISTON SYRINGE

Model Number	309579
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 11 bd luer-lok¿ 3ml w/ndl experienced missing label information.The following information was provided by the initial reporter: 11 syringes have been identified, so far, as missing the printed product information on the backside of the syringe sterile barrier.Any injuries and/or harm?: no.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this.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 11 bd luer-lok¿ 3ml w/ndl experienced missing label information.The following information was provided by the initial reporter: 11 syringes have been identified, so far, as missing the printed product information on the backside of the syringe sterile barrier.Any injuries and/or harm?: no.
Additional Manufacturer Narrative
H6: investigation summary: it was reported the syringes are missing the printed product information on the backside of the syringe sterile barrier.To aid in the investigation, one photo was received for evaluation by our quality team.The photo shows two packaging blisters, material 309579, with the top web facing towards the camera.One package is from batch number 2140273.The second packaging blister is missing its unique device identifying information entirely.The observed condition was non-conforming per product specification and is associated with the packaging printing process.The unique device identifying information that was missing in the complaint photo is printed on the unit packaging during each index of the packaging machine.The printer runs off ink cartridges that supply the ink through the system onto the top web of the packaging.In-process 2d barcode scanners are present on the packaging machinery to verify presence of a barcode on each package.If an anomaly, missing barcode, unreadable barcode, etc., is detected in three consecutive indexes of the packaging machine the process will stop and require operator intervention to remove affected packages and address any failure modes on the printer.A one-off anomaly can occur if tension to the top web is affected via a machine jam or operator intervention of some kind.While rare, if a one-off failure occurs in the indexing sequence, due to top web tension being affected, it may still be packaged.A device history record review was completed for provided material number 309579, lot number 2140273.Production record review, technician database review, and interviews with an electrical engineer and engineering technician were conducted as part of this investigation.No relevant notes related to the complaint defect were found in production records or the technical database.Additionally, all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 2140273 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.The printer runs off ink cartridges that supply the ink through the system onto the top web of the packaging.Further examination of the device history record did reveal that no cartridge changes were performed over the course of the complaint batch production, the batch prior or batch after.Over the general production of a lot, it is expected that a cartridge change would occur at least once.Common failure modes of not changing out a cartridge in a reasonable timeframe can include but are not limited to missing or illegible unique device identifying information as seen in the complaint photo received from the customer.The potential root cause for the missing unique device identifier content defect is associated with the following events: failure of the operator to change or document a printing cartridge in an adequate amount of time, failure of the operator to remove affected product after a machine stoppage for missing unique device identifying information, or intermittent failure of the printing hardware not recorded in the device history records or production logs because of web tension being affected due to a machine jam or operator intervention.The scope of this issue is likely limited based on the production records reviewed, controls in place, lack of a complaint history, and investigation above.

• Brand Name: BD LUER-LOK¿ 3ML W/NDL
• 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: 15928507
• Report Number: 1213809-2022-01179
• Device Sequence Number: 17778217
• Product Code: FMF
• UDI-Device Identifier: 50382903095792
• UDI-Public: 30382903095798
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 01/05/2023

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 Model Number: 309579
• Device Catalogue Number: 309579
• Device Lot Number: 2140273
• 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: 11/10/2022
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2022
• 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