MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE BLUNT FILL 5ML LL W/NDL 18X1-1/2; PISTON SYRINGE

Model Number	305062
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 5 syringes blunt fill 5ml ll w/ndl 18x1-1/2 had foreign contaminates found in their sealed packaging before use.The following information was provided by the initial reporter: "these are contaminated on the inside of the packaging and the packaging is still sealed.All were in the supply bin located in the supply room which is managed by materials management.".
Additional Manufacturer Narrative
H.6.Investigation summary: two photos and five 5ml syringes with needles in one opened and four sealed packages were received, confirmed to be from batch #8197829 (p/n 305062).The samples were visually evaluated.The syringe, the needle and the inside of the packaging in the opened sample were found to have large amounts of grease foreign matter residue.The fm was outside the fluid path.The four sealed samples were found to have small amounts of grease residue in similar spots on all syringes.The location was close to the bottom of the barrel between 1ml and zero line and base of the needle cap.The fm was larger than level 3 in size, outside the fluid path and rejectable per product specification.Potential root cause for the grease foreign matter defect is associated with the assembly process.It is likely due to over greasing of machine components during work performed on the machine.No corrective actions are necessary based on the defective rate identified.Batch 8197829 is considered in compliance with our product specification requirements.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.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 5 syringes blunt fill 5ml ll w/ndl 18x1-1/2 had foreign contaminates found in their sealed packaging before use.The following information was provided by the initial reporter: "these are contaminated on the inside of the packaging and the packaging is still sealed.All were in the supply bin located in the supply room which is managed by materials management.".

• Brand Name: SYRINGE BLUNT FILL 5ML LL W/NDL 18X1-1/2
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9700069
• Report Number: 1213809-2020-00087
• Device Sequence Number: 610163
• Product Code: FMF
• UDI-Device Identifier: 30382903050629
• UDI-Public: 30382903050629
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 03/13/2020

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: 06/30/2023
• Device Model Number: 305062
• Device Catalogue Number: 305062
• Device Lot Number: 8197829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 03/16/2020
• 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