MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 3 ML BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP

Catalog Number	309606
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that 3 ml bd¿ safety-lok¿ bd¿ disposable syringe with bd luer-lok¿ tip leaked "from the top".Reporter states that the needle was secure and when the plunger was being pushed down the medicine started to leak and nothing was coming from the end of the needle.No serious injury or medical intervention was reported.
Event or Problem Description
It was reported that 3 ml bd safety-lok bd disposable syringe with bd luer-lok tip leaked "from the top".Reporter states that the needle was secure and when the plunger was being pushed down the medicine started to leak and nothing was coming from the end of the needle.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Due to an it issue beginning on (b)(6) 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 manufacture: yes.67 sealed packaged 3ml safety-lok syringes and 5 loose 3ml safety-lok syringes with needles attached were received, confirmed to be from batch #7299859 (p/n 309606).The samples were visually evaluated.67 sealed ¿ one syringe package was found with excess trim, however package integrity was not compromised.No other defects were observed.5 loose ¿ samples appeared used.Syringes have live needles and contain clear liquid.Further evaluation was not performed on these 5 syringes due to potential handling risk.Leak test was performed per procedure on the 67 packaged syringes.All 67 syringes passed with no leakage found.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Root cause not defined since defects were not confirmed in the samples received.No corrective actions recommended since product defect was not confirmed.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.

• Brand Name: 3 ML BD¿ SAFETY-LOK¿ BD¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7749334
• Report Number: 1213809-2018-00507
• Device Sequence Number: 1678268
• Product Code: FMI
• UDI-Device Identifier: 30382903096061
• UDI-Public: 30382903096061
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K944757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2018

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 Expiration Date: 10/31/2022
• Device Catalogue Number: 309606
• Device Lot Number: 7299859
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 08/03/2018
• Supplement Report FDA Received Date: 09/04/2018
• 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