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

Model Number	300866
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd¿ eccentric luer slip tip syringe ce mark the plunger was broken.The following information was provided by the initial reporter: plunger broken.
Additional Manufacturer Narrative
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: d.9.Device available for eval?: yes, d.9.Returned to manufacturer on: 28-mar-2022.H.6.Investigation: one photo and one physical sample was provided to our quality team for investigation.Upon visual inspection, the thumb press was observed to be broken.A device history record review found no non-conformances associated with this issue during production of lot 2105010.The areas where pieces move within the manufacturing area are protected to avoid damage on the product.Final products in this manufacturing line, for this reference and lot size are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.While we could not identify a direct issue, it was determined the damage was likely caused as a result of the product jamming within the manufacturing equipment.
Event or Problem Description
It was reported while using bd¿ eccentric luer slip tip syringe ce mark the plunger was broken.The following information was provided by the initial reporter: plunger broken.

• Brand Name: BD¿ ECCENTRIC LUER SLIP TIP SYRINGE CE MARK
• 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: 13830020
• Report Number: 3003152976-2022-00107
• Device Sequence Number: 990604
• Product Code: FMF
• UDI-Device Identifier: 30382903008668
• UDI-Public: 30382903008668
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 04/05/2022

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: 04/30/2026
• Device Model Number: 300866
• Device Catalogue Number: 300866
• Device Lot Number: 2105010
• 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: 03/03/2022
• Supplement Date Received by Manufacturer: 04/05/2022
• Initial Report FDA Received Date: 03/20/2022
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2021
• 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