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

Catalog Number	305064
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 before use of the bd¿ luer-lok¿ blunt fill needle that there was moisture on the stopper attached with the plunger.There was no report of exposure, serious injury or medical intervention.
Event or Problem Description
It was reported that before use of the bd¿ luer-lok¿ blunt fill needle that there was moisture on the stopper attached with the plunger.There was no report of exposure, serious injury or medical intervention.It was reported that 132 devices were affected.
Additional Manufacturer Narrative
Correction: b.5.Describe event or problem: it was reported that before use of the bd¿ luer-lok¿ blunt fill needle that there was moisture on the stopper attached with the plunger.There was no report of exposure, serious injury or medical intervention.It was reported that 132 devices were affected.H.6.Investigation summary: 643 sealed packaged 10ml syringes with blunt fill needles were received, confirmed to be from batch #8218675 (p/n 305064).They were visually evaluated.627 syringes were found to have no defects, while 16 syringes were observed to have elevated amount of silicone presence on the stopper.The amount observed was excessive per product specification.Furthermore, 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 please note that silicone is an inert, non-toxic medical substance used as a lubricant for disposable hypodermic products.It is an integral part of the syringe, enabling it to perform as required in various clinical applications and does not present a safety or efficacy issue nor does it impact product function.The silicone application process is designed to provide an even distribution of silicone on the interior of the syringe barrel.Silicone has been in use in this application for over 20 years.No reports are known of adverse clinical effects associated with these products and unintentional delivery of silicone fluid lubricant.Potential root cause for the excess silicone presence defect is associated with the assembly process.No corrective actions are necessary based on the defective rate identified.

• Brand Name: BD¿ LUER-LOK¿ BLUNT FILL NEEDLE
• Common Device Name: HYPODERMIC SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8056803
• Report Number: 1213809-2018-00758
• Device Sequence Number: 2463134
• Product Code: FMF
• UDI-Device Identifier: 30382903050643
• UDI-Public: 30382903050643
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/11/2019

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 Expiration Date: 07/31/2023
• Device Catalogue Number: 305064
• Device Lot Number: 8218675
• Initial Date Received by Manufacturer: 10/22/2018
• Supplement Date Received by Manufacturer: 10/22/2018
• Initial Report FDA Received Date: 11/09/2018
• Supplement Report FDA Received Date: 01/11/2019
• 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