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

Catalog Number	300613
Medical Device Problem Codes	Leak/Splash (1354); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the stopper on the 20 ml bd¿ eccentric luer slip tip syringe was loose.The following was translated from french to english: the rubber of the plunger of a 20ml syringe is not airtight.The leak occurred while the syringe was being used.
Event or Problem Description
It was reported that the stopper on the 20 ml bd¿ eccentric luer slip tip syringe was loose.The following was translated from french to english: the rubber of the plunger of a 20ml syringe is not airtight.The leak occurred while the syringe was being used.
Additional Manufacturer Narrative
Pr 8971913 follow up mdr for device evaluation: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for the reported lot 2308754, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this incident.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, including leakage testing.Ten retained samples of lot 2308754 were used for additional evaluation.The product was visually inspected, no defects or damage was noted on any of the syringe components that could lead to a leak and all stoppers were verified to be properly assembled on to the plunger rod.Leakage testing was performed and product was verified to meet required specification.Based on the available information, we cannot identify a root cause at this time.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.

• Brand Name: 20 ML BD¿ ECCENTRIC LUER SLIP TIP SYRINGE
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17917003
• Report Number: 3003152976-2023-00458
• Device Sequence Number: 2956608
• Product Code: FMF
• UDI-Device Identifier: 30382903006138
• UDI-Public: (01)30382903006138
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2023

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: 2308754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2023
• 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