MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SYRINGE 20 ML; PISTON SYRINGE

Catalog Number	UNKNOWN
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 20 ml had leakage.The following information was provided by the initial reporter: during use: propofol leaked between the sealing ring during use, but did not leak further.Only as far as the middle.The customer has disposed of the packaging and does not know the lot number additional information provided: "no one got impacted".
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4).Follow up mdr for device evaluation: one photo and one physical sample was provided to our quality team for investigation.Through visual inspection of the provided photo, liquid is observed past the stopper ribs, verifying the reported concern.The returned product was thoroughly inspected, there was no damage observed on the syringes or any components that could contribute to a leak, and the stopper was verified to be properly assembled on the plunger.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.As the lot involved in this incident is unknown, a device history review cannot be performed.Leakage testing was performed on the the returned syringe, the product was verified to meet required specification and no leakages were observed.Based on our investigation and sample evaluation, we are not able to identify a root cause related to our product or manufacturing process at this time.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: BD SYRINGE 20 ML
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23075633
• Report Number: 3003152976-2025-00527
• Device Sequence Number: 20020937
• Product Code: FMF
• UDI-Device Identifier: 00382903009121
• UDI-Public: (01)00382903009121
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/13/2025

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 09/17/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown