MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 20ML E/T; SYRINGE, PISTON

Catalog Number	300613
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	04/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.
Event or Problem Description
Oily substance visible in the 20ml syringe.Greasy substance in the 20ml squirt, easily visible.Customer concerned about possible health risks.Same complaint was reported on 11-03 for the 50ml syringe.
Additional Manufacturer Narrative
(b)(4) follow up mdr for correction/device evaluation: correction: following submission of initial mdr, it was identified the second impacted lot was not submitted.Additional impacted lot 2311127.Batch creation: 2023-11-27.Batch expiration: 2028-10-31.Full udi: (b)(4).Device evaluation: no photos or physical samples of the 20ml syringe involved in this incident, were available for investigation.Lubricant is employed during the syringe assembly process to help facilitate movement of the plunger and stopper.The silicone employed in this product is a medical grade silicone authorized for product use.Silicone content tests are performed during the manufacturing process of each lot number.Results were reviewed for lot 2311127 and 2312044 and were found to be within specification.A device history review was performed for reported lots 2311127 and 2312044, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Six retained samples were used for additional evaluation.All product was inspected, no evidence of silicone was observed within the syringes and silicone content testing confirmed the product met required specifications.Due to the viscosity of the lubricant, it is possible to see evidence of it when moving the stopper from being fully seated at the top of the syringe, this does not indicate that the silicone is in excess.A project has been initiated to further review our silicone process.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: SYRINGE 20ML E/T
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19096675
• Report Number: 3003152976-2024-00226
• Device Sequence Number: 17959100
• Product Code: FMF
• UDI-Device Identifier: 30382903006138
• UDI-Public: (01)30382903006138
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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: Health Professional
• Device Catalogue Number: 300613
• Device Lot Number: 2312044
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2024
• Supplement Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 09/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown