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

Catalog Number	30964220
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material: 30964220.Lot: 3264115.It was reported that the bd syringe 10ml ll w/ndl 21gx1in barrel flange was damaged.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.It was reported to fresenius medical care by a clinical manager via email that on (b)(6)2024.The syringe is leaking from the stopper side, and there are noticeable dents and irregularities in its shape.Complaint#: (b)(4).Product: bd 10ml luer-lok syringe 21gx1in_3096422.Product #: 15-6422-0.Lot number#: 3264115.Additional information provided: 1) can you please provide an exact date of event in format dd-mmm-yyyy? 2/12/2024, 03/12/22024, 04/12/2024.2) what was the impact to the patient? any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.No adverse event, medication overspill and blood leak but detected and resolved before turning into adverse event.3) any sample or photo available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? sample available.Clinic address - (b)(6).
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: two photos and six 10ml syringes were received by our quality team for evaluation.The photos show red liquid leaking past the stopper.During visual inspection of the six physical samples, it was observed that the barrel of the syringe was dented.This damage could cause leakage.The samples were then sent for testing.All six of the damaged syringes showed leakage.The reported incident could be 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
No additional information.

• 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: 21076435
• Report Number: 9614033-2024-00091
• Device Sequence Number: 15564312
• 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: GA
• 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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2024
• Supplement Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 01/05/2025
• 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