MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD¿ 20 ML ECCENTRIC LUER SLIP TIP SYRINGE CE; PISTON SYRINGE

Catalog Number	300613
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 2 bd¿ 20 ml eccentric luer slip tip syringe ce had "black" foreign matter in syringes.The following information was provided by the initial reporter, translated from french to english: our operating room found a suspicious black element in two 20-ml sterile syringes from bd.
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 13jun2023.H6: investigation summary: two used sample syringes and photos received by our quality team for investigation.Through visual evaluation, a black particle is observed in the fluid path of the syringes.Since syringes are contaminated, fourier transform infrared spectroscopy could not be performed to identify the foreign matter.A device history review was performed for the reported lot 2304060, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Manufacturing for this product is performed in a clean room which is kept under a positive pressure to reduce the chance of foreign matter.The assembly station has a de-ionizer and vacuum system used to remove any particles inside the barrel.While we cannot identify a direct issue, the particle likely generated during the assembly process due to contamination.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.
Event or Problem Description
It was reported that 2 bd¿ 20 ml eccentric luer slip tip syringe ce had "black" foreign matter in syringes.The following information was provided by the initial reporter, translated from french to english: our operating room found a suspicious black element in two 20-ml sterile syringes from bd.

• Brand Name: BD¿ 20 ML ECCENTRIC LUER SLIP TIP SYRINGE CE
• 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 ; 8448235433
• MDR Report Key: 17164802
• Report Number: 3003152976-2023-00241
• Device Sequence Number: 17537323
• Product Code: FMF
• UDI-Device Identifier: 00382903006137
• UDI-Public: (01)00382903006137
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 07/24/2023

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 Catalogue Number: 300613
• Device Lot Number: 2304060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 06/20/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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