MAUDE Adverse Event Report: BECTON DICKINSON, S.A. MICROLANCE; NEEDLES, HYPODERMIC

Catalog Number	301300
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported abbott has received complaint from a client regarding a leaking bd reconstitution (mixing) needle.The leak occurs at the point where the needle tube is bonded into the hub.Please note that this notification is for awareness and trending purposes only and does not constitute an official complaint.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 301300 and lot number 220814.The review did not reveal any abnormalities detected during the production process that could have contributed to the reported defect, and all quality tests were found to be within specification.To aid in the investigation of this issue, one (1) picture sample was received for evaluation by our quality team.Through examination of the picture, a drop of liquid was observed on the hub component which is understood as being caused by leakage.Twenty (20) retained samples of the reported lot number were obtained from the manufacturing facility for further evaluation.The retained needle samples were assembled with a bd discardit 2ml syringe.No signs of defective hub connection or leakage were observed.Although leakage was observed through the picture sample, an exact cause could not be determined based on the investigation results.During the molding process, molten plastic is injected at very high temperatures to fill the mold cavity and form the hub component.When the plastic cools between molding cycles, a very small solidified plastic particle¿known as a ¿cold drop¿¿may remain at the injection point of the mold.During the next molding cycle, this particle is injected together with the molten plastic and becomes mixed into the material forming the hub.This phenomenon is inherent to any molding process and should not pose any issue for the product.However, in some very isolated cases, this ¿cold drop¿ may remain very close to the injection point, creating a small crack in the hub that can lead to leakage.Our molds are designed to minimize and prevent this issue, and the likelihood of encountering the reported nonconformance is extremely low and only on a very isolated basis.If this issue were to reoccur, we would greatly appreciate the opportunity to review the affected physical sample(s).At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

• Brand Name: MICROLANCE
• Common Device Name: NEEDLES, HYPODERMIC
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23866485
• Report Number: 3002682307-2025-00145
• Device Sequence Number: 11916853
• Product Code: FMI
• UDI-Device Identifier: 00382903013005
• UDI-Public: (01)00382903013005(10)220814
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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: 301300
• Device Lot Number: 220814
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2025
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown