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
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
Material #:30964220; batch#: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: it was reported by customer that the 10cc syringe plunger not working and blood / medications leak past syringe.Verbatim: rcc received a complaint via email.Complaint#: (b)(4), product: bd 10ml luer-lok syringe 21gx1in_3096422, product #: 15-6422-0 and lot number#: 3264115.Complaint: it was reported to fresenius medical care by a charge nurse via email that 10cc syringe plunger not working.Blood + medications leak past syringe plunger.
Additional Manufacturer Narrative
Investigation results: two photos were received by the quality team for investigation.One photo shows a 10 ml syringe outside its primary packaging (blister) where it is possible to see that the liquid passes the stopper.The other photo shows a primary packaging (blister) on the printing side, where the code number (30964220) and lot (3264115) reported by the customer are confirmed.Based on photo 1, the reported incident was able to 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 related to this incident were found.Based on the quality team's investigation, the probable root cause was determined to be linked to the process of molding the cylinder.Although there are no physical samples for this complaint, lot 3264115 was previously reported for the leak defect in which samples were received to carry out the analysis of the defect.This investigation resulted in the cylinder having a dent which causes the liquid to leak.Based on the quality team's investigation, the probable root cause was determined to be linked to the process of molding the cylinder which caused the dent.
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: 21026668
• Report Number: 9614033-2024-00089
• Device Sequence Number: 9106962
• 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: NC
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2025

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: 12/03/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• 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