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

Catalog Number	300613
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Description/event details: common name: seringue bd plastipak, commercial reference: 300613, batch / serial number: (b)(6), date of occurrence: on (b)(6) 2025.Description of non-conformit: during the injection of propofol at induction, leakage of propofol through the leaking plunger.Incomplete seal.Consequences: disorganisation of work.Vigilance over the rest of the batch, device retained for expert appraisal: yes.Please give us your analysis of these quality defects and kindly send us an equivalent replacement.
Additional Manufacturer Narrative
(b)(6) follow up mdr for device evaluation: no photos or physical samples of reported material, 300613, have been received for investigation.A device history review was performed for the reported lot 2410052; no deviations or non-conformances were identified during the manufacturing process that could have contributed to this incident.Six retained samples of the reported lot were used for additional evaluation.The products were 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.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.The retained samples of the same lot underwent these tests and product was verified to meet required specifications, no leakages were observed.Based on our investigation, we cannot identify a root cause at this time.To date, there have been no other similar events reported for this lot.Complaints received for this device and reported condition will be monitored by our quality team for signs of emerging trends.
Event or Problem Description
No additional information.

• Brand Name: SYRINGE 20ML E/T
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21279988
• Report Number: 3003152976-2025-00030
• Device Sequence Number: 18115940
• Product Code: FMF
• UDI-Device Identifier: 00382903006137
• UDI-Public: (01)00382903006137(11)241014(17)290930(10)2410052
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2025

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: Health Professional
• Device Catalogue Number: 300613
• Device Lot Number: 2410052
• 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: 01/24/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown