MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 18 G X 1 1/2 IN., STERILE; PISTON SYRINGE

Model Number	309580
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	02/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd luer-lok¿ syringe with attached needle 18 g x 1 1/2 in., sterile foreign matter was found in the barrel.There was no report of patient impact.The following information was provided by the initial reporter: material no:309580 batch no: 1081263.  it was reported by the consumer oily substance in the barrel.
Additional Manufacturer Narrative
A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd luer-lok¿ syringe with attached needle 18 g x 1 1/2 in., sterile foreign matter was found in the barrel.There was no report of patient impact.The following information was provided by the initial reporter: material no:309580 batch no: 1081263.  it was reported by the consumer oily substance in the barrel.
Additional Manufacturer Narrative
A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.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.
Event or Problem Description
It was reported while using bd luer-lok¿ syringe with attached needle 18 g x 1 1/2 in., sterile foreign matter was found in the barrel.There was no report of patient impact.The following information was provided by the initial reporter: material no:309580.Batch no: 1081263.  it was reported by the consumer oily substance in the barrel.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 18 G X 1 1/2 IN., STERILE
• 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: 13598674
• Report Number: 1213809-2022-00100
• Device Sequence Number: 19296923
• Product Code: FMF
• UDI-Device Identifier: 30382903095804
• UDI-Public: 30382903095804
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2022

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: 02/28/2026
• Device Model Number: 309580
• Device Catalogue Number: 309580
• Device Lot Number: 1081263
• 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: 02/14/2022
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 02/25/2022
• Supplement Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2021
• 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