MAUDE Adverse Event Report: BECTON DICKINSON, S.A. 50 ML BD¿ ECCENTRIC LUER SLIP TIP SYRINGE CE MARK STERILE; PISTON SYRINGE

Model Number	300866
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	01/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using 50 ml bd¿ eccentric luer slip tip syringe ce mark sterile foreign matter was found in the fluid path.There was no report of patient impact.The following information was provided by the initial reporter: a syringe b+d 50/60ml luer was sorted out because a small gray-brown particle was detected in the syringe.
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported while using 50 ml bd¿ eccentric luer slip tip syringe ce mark sterile foreign matter was found in the fluid path.There was no report of patient impact.The following information was provided by the initial reporter: a syringe b+d 50/60ml luer was sorted out because a small gray-brown particle was detected in the syringe.
Event or Problem Description
It was reported while using 50 ml bd¿ eccentric luer slip tip syringe ce mark sterile foreign matter was found in the fluid path.There was no report of patient impact.The following information was provided by the initial reporter: a syringe b+d 50/60ml luer was sorted out because a small gray-brown particle was detected in the syringe.
Additional Manufacturer Narrative
H6: investigation summary one physical sample and one photo were provided to our quality team for investigation.Upon inspection of the product, a brown particle was observed to be embedded within the syringe barrel.A device history review was performed for reported lot 2108005, no deviations or non-conformances related to the reported issue were identified during the manufacturing process.Molding parameters were reviewed and verified all machines were operating within specified limits.Ten retained samples of the same lot were used for additional evaluation.All product was inspected and no foreign material was observed within any of the syringes.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Machines undergo routine cleaning and maintenance and injection machines are ran prior to use to remove any excess materials, rejecting the first few pieces.While we could not identify a direct issue, this incident was determined have occurred due to material generating during the molding process and becoming embedded within the device as seen in the sample and photo provided.Complaints received for this device and defect will be monitored by our quality team for signs of emerging trends.

• Brand Name: 50 ML BD¿ ECCENTRIC LUER SLIP TIP SYRINGE CE MARK STERILE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13500803
• Report Number: 3003152976-2022-00057
• Device Sequence Number: 5328241
• Product Code: FMF
• UDI-Device Identifier: 30382903008668
• UDI-Public: 30382903008668
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2022

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: 07/31/2026
• Device Model Number: 300866
• Device Catalogue Number: 300866
• Device Lot Number: 2108005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 02/09/2022
• Supplement Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown