MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SYRINGE 20ML L/T SSU NRFIT; PISTON SYRINGE WITH NEURAXIAL CONNECTOR ¿ EPIDURAL, PERIPHERAL, AND/OR INDIRECT

Catalog Number	400182
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.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 20ml l/t ssu nrfit had foreign matter.The following information was provided by the initial reporter: it was reported that black spots on the inside of the nrf connection (see attachment) additional information provided: 1.Could you please confirm the material number of the product? sku 400182 - lot 4080696.2.It came to our attention that samples are available for investigation.Could you please specify if the samples are: unused (before use) the syringe is unused, but the packaging has been opened, so only the syringe is available.Used (during or after use).
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation.It was reported that black spots were present inside the connection.To support the investigation, one sample without blister packaging and two photographs were provided for evaluation by the quality team.A visual inspection was conducted.The syringe barrels luer-lok and luer tip exhibit dark specks of embedded degraded resin.The two photographs depict the same sample that was received.No other defects or imperfections were observed.Embedded degraded resin in components typically occurs at startup or intermittently during the injection molding process; the degraded material can dislodge and become incorporated into molded parts.A device history record review was completed for material number 400812, lot 4080696.The review did not identify any quality issues during the production of this lot that could have contributed to the reported condition.There were no related quality notifications.All processes and final inspections met specification requirements.To date, no other similar events have been reported for this lot.Based on the investigation and analysis of the returned sample, the customer reported condition is confirmed.

• Brand Name: BD SYRINGE 20ML L/T SSU NRFIT
• Common Device Name: PISTON SYRINGE WITH NEURAXIAL CONNECTOR ¿ EPIDURAL, PERIPHERAL, AND/OR INDIRECT
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23722296
• Report Number: 1911916-2025-00777
• Device Sequence Number: 10349721
• Product Code: QEH
• UDI-Device Identifier: 00382904001827
• UDI-Public: (01)00382904001827(11)240320(17)290430(10)4080696
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K192538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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: Other
• Device Catalogue Number: 400182
• Device Lot Number: 4080696
• 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: 11/11/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown