MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD PRECISIONGLIDE¿ LUER-LOK¿ SYRINGE; SYRINGE WITH NEEDLE

Catalog Number	309640
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported with the use of the bd precisionglide¿ luer-lok¿ syringe there was an issue with holes in the needles causing leakage.There was no report of injury or medical intervention.
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.A device history record review could not be performed as lot number is unknown.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 with the use of the bd precisionglide luer-lok syringe there was an issue with holes in the needles causing leakage.There was no report of injury or medical intervention.

• Brand Name: BD PRECISIONGLIDE¿ LUER-LOK¿ SYRINGE
• Common Device Name: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8021626
• Report Number: 1213809-2018-00720
• Device Sequence Number: 1381712
• Product Code: FMF
• UDI-Device Identifier: 00382903096404
• UDI-Public: 00382903096404
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2018

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: 309640
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 10/11/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 11/16/2018
• 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