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

Model 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	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that syringe 20ml e/t contained foreign matter.The following information was provided by the initial reporter: "i noticed today that bd plastipak 20ml and 30ml syringes presented with a clear liquid substance residue inside once plunger was pushed up fully and drawn back prior to use.".
Event or Problem Description
It was reported that syringe 20ml e/t contained foreign matter.The following information was provided by the initial reporter: "i noticed today that bd plastipak 20ml and 30ml syringes presented with a clear liquid substance residue inside once plunger was pushed up fully and drawn back prior to use.".
Additional Manufacturer Narrative
H6: investigation summary: several samples have been provided to our quality team for investigation.Upon visual inspection, no defects or signs of excess silicone can be observed inside the syringe.A device history review was performed for reported lot 2007109, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Lubricant is employed during the syringe assembly process to lubricate the cylinders in the silicone station.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.Testing was performed on the returned samples, results verified the amount of silicone was with the required limits.Based on the investigation results, no manufacturing related defects could be identified and therefore, a cause for the reported incident could not be determined.It is possible the silicone noted by the customer was a result of poor distribution of the material inside the barrel.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.

• Brand Name: SYRINGE 20ML E/T
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 12230304
• Report Number: 3003152976-2021-00422
• Device Sequence Number: 3035846
• Product Code: FMF
• UDI-Device Identifier: 30382903006138
• UDI-Public: 30382903006138
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2021

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: 06/30/2025
• Device Model Number: 300613
• Device Catalogue Number: 300613
• Device Lot Number: 2007109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1