MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 23 G X 1 1/2 IN.; PISTON SYRINGE

Catalog Number	309589
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using a bd luer-lok¿ syringe with attached needle 23 g x 1 1/2 in., leakage occurred.The following information was provided by the initial reporter: when the diluent was injected into the vial, the luerlock of the syringe started spraying diluent and an unknown amount of diluent went into the vaccine vial.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Fda notified: the initial reporter also notified the fda via medwatch # mw5110482.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 while using a bd luer-lok¿ syringe with attached needle 23 g x 1 1/2 in., leakage occurred.The following information was provided by the initial reporter: when the diluent was injected into the vial, the luerlock of the syringe started spraying diluent and an unknown amount of diluent went into the vaccine vial.
Additional Manufacturer Narrative
H.6.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Furthermore, 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.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE 23 G X 1 1/2 IN.
• 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: 15136552
• Report Number: 1213809-2022-00443
• Device Sequence Number: 14761017
• Product Code: FMF
• UDI-Device Identifier: 00382903095896
• UDI-Public: 00382903095896
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2022

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: 10/31/2025
• Device Catalogue Number: 309589
• Device Lot Number: 0308897
• 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: 06/30/2022
• Supplement Date Received by Manufacturer: 07/30/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2020
• 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