MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETY-LOK¿ SYRINGE WITH DETACHABLE NEEDLE; SYRINGE WITH HYPODERMIC NEEDLE

Catalog Number	309592
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.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 the safety mechanism on a bd safety-lok¿ syringe with detachable needle failed as it "was not locking in place".There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: no samples displaying the condition reported are available for examination.We were unable to fully investigate this incident.Dhr review for batch 7338970 (p/n 309592): manufacturing dates: 12/14/2017 to 12/18/2017.Batch quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7338970 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Investigation summary: a root cause could not be determined.

• Brand Name: BD SAFETY-LOK¿ SYRINGE WITH DETACHABLE NEEDLE
• Common Device Name: SYRINGE WITH HYPODERMIC NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7531733
• Report Number: 1213809-2018-00316
• Device Sequence Number: 2018857
• Product Code: FMI
• UDI-Device Identifier: 30382903095927
• UDI-Public: 30382903095927
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K944757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 309592
• Device Lot Number: 7338970
• Initial Date Received by Manufacturer: 04/27/2018
• Supplement Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other