MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB MCK; PISTON SYRINGE

Catalog Number	306619
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
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
The following information was provided by the initial reporter: material # 306619 batch # 5034227.Verbatim: rcc received a complaint via email.Email(s) attached.Complaint number (b)(4).Report date 11/18/2025.Factory/manufacturer becton dickinson.Mfr reorder # (b)(4).Product name syr/ndl, sfty (b)(6) lot / serial number (b)(6).Product concern graduations are not correct on syringe.Additional information provided: "when drawing up vaccines with either of them they usually only came between 0.3-0.4 ml in volume instead of 0.5 ml".
Additional Manufacturer Narrative
(b)(4).Follow up.It was reported graduations are not correct on the syringe.Because no physical sample was returned, a comprehensive evaluation could not be performed.To support the investigation, three photographs of 3ml luer lok syringes with 25 gauge, 1 inch needles from lot 5034227 were provided to quality for review.The first image depicts the carton with the affixed label containing all relevant product information.The second image shows the top web side of two pouches, also displaying the applicable product information.The reported condition was not evident in either of these images.The third image shows the clear web side of two sealed pouches with the syringe and needle visible.In one unit, the graduation scale is oriented inward, so only shadows of the markings can be seen, in the other, the graduations face outward and are partially visible.The visible graduations on this unit are consistent with product specifications.A device history record review was completed for material number 306619, lot 5034227.The review did not identify any quality issues during manufacture that could have contributed to the reported condition, and no related quality notifications were found.All processes and final inspections were performed in accordance with specification requirements.Additional device histories for the syringe lots used in manufacturing this final lot were also reviewed, visual inspections were conducted per requirements, with no quality notifications related to the reported condition.The lots were inspected and accepted according to the inspection control plan, approved for shipment, and found compliant with product specifications.To date, no other similar events have been reported for this lot.

• Brand Name: BD SYRINGE 3ML LL W/NDL SFTYGLD 25X1 RB MCK
• Common Device Name: PISTON SYRINGE
• 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: 23796449
• Report Number: 1911916-2025-00792
• Device Sequence Number: 14839428
• Product Code: FMF
• UDI-Device Identifier: 10612479262741
• UDI-Public: (01)10612479262741
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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: 306619
• Device Lot Number: 5034227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown