MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ SYRINGE LL W/NDL SFTYGLD RB; GENERAL-PURPOSE SYRINGE

Catalog Number	305924
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: 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 that a bd¿ syringe ll w/ndl sftygld rb was leaked during use.
Event or Problem Description
It was reported that a bd syringe ll w/ndl sftygld rb was leaked during use.
Additional Manufacturer Narrative
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.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.
Event or Problem Description
It was reported that a bd¿ syringe ll w/ndl sftygld rb was leaked during use.
Additional Manufacturer Narrative
In section h.10 of the previously submitted mdr, sections d.1 and h.1 were incorrectly referenced as the medical device expiration date and device manufacture date.This supplemental mdr is being submitted to correct those references to show the following: d.4 medical device expiration date h.4 device manufacture date.

• Brand Name: BD¿ SYRINGE LL W/NDL SFTYGLD RB
• Common Device Name: GENERAL-PURPOSE SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8125066
• Report Number: 1213809-2018-00860
• Device Sequence Number: 16536501
• Product Code: MEG
• UDI-Device Identifier: 30382903059240
• UDI-Public: 30382903059240
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/25/2019

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: 305924
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 11/16/2018; 11/16/2018
• Initial Report FDA Received Date: 12/03/2018
• Supplement Report FDA Received Date: 12/14/2018; 01/28/2019
• 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