MAUDE Adverse Event Report: EMBECTA MEDICAL I LLC - HOLDREGE, NE SYRINGE 1.0ML 28GA 1/2IN BLS 500 BDD CA; Syringe, piston

Model Number	329424
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Account- (b)(6).Sku# unknown item description: bd insulin syringe 1ml lot# 3121576 quantity- unknown.Country- usa incident description- we wanted to inform the company that we found this bd insulin syringe 1ml (lot no 3121576) with the needle poking through the cap.It did poke one of our associates.The company may want to investigate into this.Please check the attachment for additional information.
Additional Manufacturer Narrative
This medwatch submission is both an initial and supplemental filing.Investigation of the results can be seen below: investigation summary: no physical samples were received however the investigation was performed based on the photo(s) provided.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.Embecta was able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.No definitive root cause determined at this time.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situation analysis (sa) is required at this time.

• Brand Name: SYRINGE 1.0ML 28GA 1/2IN BLS 500 BDD CA
• Common Device Name: Syringe, piston
• Manufacturer (Section D): EMBECTA MEDICAL I LLC - HOLDREGE, NE
• Manufacturer Contact: anna garbowska-zakrzewski ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 22868917
• Report Number: 3024508819-2025-00276
• Device Sequence Number: 18389032
• Product Code: FMF
• UDI-Device Identifier: 30382903294245
• UDI-Public: 30382903294245
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K190054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2025

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
• Device Model Number: 329424
• Device Lot Number: 3121576
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown