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

Catalog 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	12/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 26 of the bd luer-lok¿ 3ml w/ndl were missing the printed product information.The following information was provided by the initial reporter: 26 syringes have been identified, so far, as missing the printed product information on the backside of the syringe sterile barrier.
Event or Problem Description
It was reported that 26 of the bd luer-lok¿ 3ml w/ndl were missing the printed product information.The following information was provided by the initial reporter: 26 syringes have been identified, so far, as missing the printed product information on the backside of the syringe sterile barrier.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 18-jan-2023.H6: investigation summary: four hundred and ninety-seven samples were provided to our quality team for investigation.Through visual inspection, twenty-six samples were observed missing their unique device identifying information, one sample had incorrect stopper position, two samples had distorted/jammed stoppers and six samples had rolled graduated scale.Potential root causes for the incorrect stopper position, distorted/jammed stoppers defects are associated with the assembly process and the rolled scale defect with the barrel printing process.Potential root cause for the missing unique device identifier content defect is associated with package printing process.As corrective actions, quality alert will be issued to manufacturing facility for missing label content defect.Furthermore, a device history record review was completed for provided lot number 2158080.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defects.H3 other text : see h10.

• 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: 16090902
• Report Number: 1213809-2022-01333
• Device Sequence Number: 6686405
• Product Code: FMF
• UDI-Device Identifier: 00382903095797
• UDI-Public: 00382903095797
• 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): 02/07/2023

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: 309579
• Device Lot Number: 2158080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Supplement Date Received by Manufacturer: 02/06/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2022
• 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