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

Catalog Number	309595
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2018
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 with the use of the bd safety-lok¿ syringe there was an issue with leakage.There was no report of injury or further medical intervention.
Additional Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacturer: no.
Event or Problem Description
It was reported with the use of the bd safety-lok¿ syringe there was an issue with leakage.There was no report of injury or further medical intervention.
Additional Manufacturer Narrative
Investigation summary: lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.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.Based on no sample, the investigation concluded: unconfirmed: bd was not able to confirm the customer¿s indicated failures.Investigation conclusion: no root cause can be determined as no samples were received.
Event or Problem Description
It was reported with the use of the bd safety-lok¿ syringe there was an issue with leakage.There was no report of injury or further medical intervention.

• 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: 7684027
• Report Number: 1213809-2018-00411
• Device Sequence Number: 920748
• Product Code: FMI
• UDI-Device Identifier: 00382903095957
• UDI-Public: 00382903095957
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K944757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2018

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: Other
• Device Catalogue Number: 309595
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 06/19/2018
• Supplement Date Received by Manufacturer: 06/19/2018; 06/19/2018
• Initial Report FDA Received Date: 07/12/2018
• Supplement Report FDA Received Date: 07/30/2018; 09/13/2018
• 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