MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETY-LOK¿ SYRINGE

Catalog Number	309594
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Initial reporter: address unavailable.Bd corporate address used.Device manufacture date: unknown.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.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Investigation conclusion bd was not able to confirm the customer¿s indicated failures.Root cause description no root cause can be determined as no samples were received.Rationale: capa is not required at this time.
Event or Problem Description
It was reported that before use of the bd safety-lok¿ syringe, that the syringes come apart when closing.There was no report of exposure, serious injury or medical intervention.
Event or Problem Description
It was reported that before use of the bd safety-lok syringe, that the syringes come apart when closing.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Reason code for no evaluation: changed from "device evaluation anticipated, but not yet begun" to "other".

• Brand Name: BD SAFETY-LOK¿ SYRINGE
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7889219
• Report Number: 1213809-2018-00640
• Device Sequence Number: 19181212
• Product Code: FMI
• UDI-Device Identifier: 30382903095941
• UDI-Public: 30382903095941
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K944757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2018

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: Other
• Device Catalogue Number: 309594
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/19/2018
• Supplement Report FDA Received Date: 09/24/2018
• 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