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	12/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd syringe 10ml ll w/ndl 21gx1in leaked.The following information was provided by the initial reporter: rcc received a complaint via email.Blood backing up into syringe; leaking infusion port.Item - 3096422 lot - 3264115.Additional information provided: 1) can you please provide date of event? 2) the provided material number 3096422, not match with batch number 3264115.Can you please provide material number if available? 3) any sample available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? 4) please share the captured photo of the event if available.5) any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.1.Date of event 12-3-2024 3.The 2 boxes of syringes have been sequestered an are available for investigation 4.No picture available 5.Amount of blood loss was not sufficient for an adverse event.Clinic address is (b)(6).
Additional Manufacturer Narrative
Investigation results: two 10ml syringes outside or their primary packaging (blister) with their separate components (stopper and plunger), four syringes inside their primary packaging (blister) and two cannulas inside a white cylinder were received by our quality team for evaluation.Six syringes have damage to the cylinder body.When extracting liquid through the syringe, the damage to the cylinder body of the syringe can cause the liquid to pass through the stopper.The reported incident was 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 damaged syringe cylinder wall occurred during production.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: 21026666
• Report Number: 9614033-2024-00090
• Device Sequence Number: 9106960
• 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: VA
• 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): 02/06/2025

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: 12/03/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 12/27/2024
• Supplement Report FDA Received Date: 02/07/2025
• 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