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	01/16/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Material #:30964220 batch#:3264115.It was reported that the bd syringe 10ml ll w/ndl 21gx1in had leakage.The following information was provided by the initial reporter: rcc received a complaint via email.It was reported to fresenius medical care by a clinical manager via email that fluids are leaking through the barrel of the 10ml syringes when pulling and pushing medications, leading to spills of blood and medication.Complaint#: (b)(4) product:bd 10ml.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
Investigation results: two photos were received by our quality team for evaluation.Upon visual inspection, it was observed red liquid was leaking past the stopper; therefore, the reported incident could be verified.A device history record review found no non-conformances associated with this issue during production of this batch.Based on the quality team's investigation, the root cause is most likely due to a dent in the cylinder of the syringe which is caused during production.Action was already taken to mitigate the issue in the future.This incident has been added to our database of reported incidents.

• 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: 21270342
• Report Number: 9614033-2025-00002
• Device Sequence Number: 3810623
• Product Code: FMF
• UDI-Device Identifier: 00382903096428
• UDI-Public: (01)00382903096428(11)240904(17)280930(10)3264115
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 03/10/2025
• 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