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

Catalog Number	309580
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2018
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 before use of the bd luer-lok¿ syringe with attached needle ¿the products were not properly sealed.¿ there was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: eleven packaged 3ml syringes with needles were received.All packages had open side seal on one side from approximately the barrel flange to the luer collar.The bottom web was frayed/not smoothly cut in that area.Six of these packages were still held together in pairs by uncut bottom web ¿ cavities of pairs were (10, 11) x 2 and (8, 9).The remaining five loose packages were cavities 9 and 10.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.In-process inspections are conducted at different points within our manufacturing process to ensure our products meet product specification.18 pieces are visually inspected every hour at the packaging process to confirm product quality.A complaint history check for lot 7338510 was performed from mar-2017 to date, one complaint reported for open seal was received.Investigation conclusion: several potential failure modes at the cutting station were identified during root causes analysis performed with subject matter experts.These include, worn crosscut springs located at the bottom and top could cause incomplete/rough knife cuts in packages, worn cylinder block could cause incomplete/rough knife cuts in packages, worn cut guide could cause incomplete/rough knife cuts in packages, and worn blades could cause incomplete/rough knife cuts.Preventive maintenance activities for the crosscut springs, the cylinder block, and the cut guide were added to the 6 weeks plan of the packaging machines.Also, a study is being performed to understand the performance of the blades used in the cutting station.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE
• Common Device Name: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7375392
• Report Number: 1213809-2018-00197
• Device Sequence Number: 13768967
• Product Code: FMF
• UDI-Device Identifier: 30382903095804
• UDI-Public: 30382903095804
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/05/2018

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: 11/30/2022
• Device Catalogue Number: 309580
• Device Lot Number: 7338510
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2018
• Supplement Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 06/05/2018
• 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