MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD SYRINGE 10ML LL W/NDL 21GX1IN; PISTON SYRINGE

Catalog Number	30964220
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 30964220, batch # 3264115.It was reported that the bd syringe 10ml ll w/ndl 21gx1in had leakage past the stopper.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Product name: bd 10ml syringe.Material/catalog number: ref: (b)(4) serial#: (b)(6).Lot number(s): 00382903096428.Date of incident (b)(6) 2024.Date bd notified, if applicable 12/20/24.Name of bd associate informed, if applicable (first and last name): description of event: multiple 10ml syringes leaking around rubber stopper when drawing up meds.Pts on heparin pump also leaking blood filled syringe from the rubber stopper.Sample availability: yes- have uncontaminated syringe from same lot that leaked when drawing up fluid.Was there any alleged injury or harm to user or patient? heparin pump leaking blood through the syringe stopper onto the machine.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation results: six photos and twenty-two 10ml syringes were received by our quality team for evaluation.The photos show red liquid passing the stopper, an assembled syringe with clear liquid, packaging, and a report of the incident.During visual inspection, it was observed that six of the twenty-two physical samples were dented.The damage to the surface of the syringe could cause leakage.The damaged syringes were sent for testing.Testing verified that there was leakage in all six samples.The incident has been verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause can be linked to production.Actions have been put in place; however, the reported lot number was manufactured prior to these actions being put into place.This incident has been added to our database of reported incidents.
Event or Problem Description
Additional information: 4 events on 12/20/2024.

• Brand Name: BD SYRINGE 10ML LL W/NDL 21GX1IN
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21149502
• Report Number: 9614033-2024-00098
• Device Sequence Number: 9236620
• Product Code: FMF
• UDI-Device Identifier: 00382903096428
• UDI-Public: (01)00382903096428(10)00382903096428
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2025

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: 30964220
• Device Lot Number: 3264115
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown