MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 5ML LS SP125; PISTON SYRINGE

Model Number	309647
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: two hundred and seventy-three 5ml syringes (material 309647) in their sealed blisterpaks were received.Two hundred and sixty-one were from batch 1019410, eight were from batch 1019409, and one each from batches 1102727, 9115907, 0170636, and 9336432.The samples were visually evaluated.Thirteen samples from batch 1019410 were found to have excessive silicone present.The normal acceptable amount of silicone was present in samples received from the other listed batches.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 excessive silicone defect from batch 1019410 is associated with the assembly process.The excess silicone is likely related to the silicone gun malfunction which was detected and corrected during the manufacturing process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batch 1019410 is considered in compliance with our product specification requirements.Since no samples displaying the reported condition were received for batches 1019409, 1102727, 9115907, 0170636, and 9336432.Potential root cause could not be defined and corrective actions are not necessary.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of these batches 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.Investigation conclusion: the aql for excess lubricant is 1.0%.(b)(4).These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batch #1019410 is considered in compliance with our product specification requirements.
Event or Problem Description
It was reported that 300 syringe 5ml ls sp125 experienced foreign matter in fluid path.The following information was provided by the initial reporter: we discovered a sticky substance inside of multiple syringes inside the sealed packaging.We audited all sealed cases with this lot number and found impacted product in three different cases.When auditing a different lot number, we did not identify the same issue.Qty impacted  300 ea.Physical confirmation of 10 different syringes (all 300 are sequestered).

• Brand Name: SYRINGE 5ML LS SP125
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 12145920
• Report Number: 1213809-2021-00485
• Device Sequence Number: 3988406
• Product Code: FMF
• UDI-Device Identifier: 30382903096474
• UDI-Public: 30382903096474
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2025
• Device Model Number: 309647
• Device Catalogue Number: 309647
• Device Lot Number: 1019410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 07/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1