MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 20ML LS S/C 48; SYRINGE, PISTON

Catalog Number	302831
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2024
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
Material: 302831.Lot: unknown.It was reported by customer that internal portion of syringe broke off inside epidural filter.Verbatim: rcc received a complaint via email.Product information: product code: 302831.Product description: syringe hypo 20cc l/s bx/48.Lot/serial #: unknown.Expiry date: 2027-01-15.Problem information: product concern ticket number: (b)(4).Date of incident: (b)(6) 2024, concern description: internal portion of syringe broke off inside epidural filter.Occurrences: 1 ea.Follow up response received on 05-may-2025.1) did the issue happen during patient use? if yes, was there any injury? if so, please describe and include any medical treatment needed as a result? r: during patient care ¿ no injury.2) could you confirm where exactly the damage occurred, whether luer part or barrel got damaged? r: luer was damaged ¿ broke off in hub of receiving device.
Additional Manufacturer Narrative
(b)(4).Follow up it was reported the internal portion of the syringe broke off inside an epidural filter.Due to the absence of a physical sample, photographic evidence, or lot number, our quality engineering team was unable to conduct a comprehensive investigation.Current quality controls are in place to identify such defects during the production process.Based on the limited investigation, the cause of the reported incident remains undetermined.If you encounter any further issues with our product, we would appreciate the opportunity to perform a thorough analysis.Examination of the involved product may provide insights into the cause of the reported failure.

• Brand Name: SYRINGE 20ML LS S/C 48
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21967456
• Report Number: 1911916-2025-00326
• Device Sequence Number: 12797384
• Product Code: FMF
• UDI-Device Identifier: 30382903028314
• UDI-Public: (01)30382903028314
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

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: 302831
• Device Lot Number: UNKNOWN
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown