MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL; SALINE, VASCULAR ACCESS FLUSH

Catalog Number	306547
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It is reported some 10ml bd syringes have been found to have narrower flanges.Incident details: three medfusion 4000 syringe pumps have come down to clinical engineering in a short time frame all reporting the same problem: ¿syringe plunger not in place¿ with an arrow pointing to a representation of the syringe barrel flange.M333717 m333711 m909775 a work order dated 09-dec-2025 was found documenting the problem; the pump subsequently came back to ce with the same issue recently.No faults were found with the pumps when bench tested.This appears to be an issue with prefilled 10ml bd syringes.Some 10ml bd syringes have been found to have narrower flanges.(1.5mm vs 2.0mm).Staff could be informed that repositioning the barrel can alleviate the problem, or the syringes with the narrow flanges removed from circulation.Additional information on 09-jan-2026.Can you please provide an exact date of event in format (mm-dd-yyyy) for lot# 5024175? <- 09 dec 2025 describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.<- inability to start drug infusion when indicated.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported that certain 10ml bd syringes appear to have narrower flanges.To support the investigation, one empty sample without flow wrap or a tip cap was received and evaluated by the quality team.Visual inspection revealed no defects or imperfections.The barrel flange measured 1.55 mm and was confirmed to be correct for this product design.To contextualize the customers observation, a 10ml non prefilled syringe manufactured at another bd site was also measured, its barrel flange measured 2.05 mm, consistent with the customers report.Both measurements are correct and reflect different bd designs.A device history record review was completed for material number 306547, lot 5024175.The review did not identify any quality issues during production that could have contributed to the reported condition, and there were no related quality notifications.All processes and final inspections complied with applicable specifications.To date, no similar events have been reported for this lot.Based on the investigation, including analysis of the returned sample, the reported condition could not be confirmed.

• Brand Name: SYR 10ML PUMP COMPATIBLE SALINE 10ML FIL
• Common Device Name: SALINE, VASCULAR ACCESS FLUSH
• 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: 24069473
• Report Number: 1911916-2026-00010
• Device Sequence Number: 9350600
• Product Code: FOZ
• UDI-Device Identifier: 00382903065479
• UDI-Public: (01)00382903065479
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K003553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2026

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: 306547
• Device Lot Number: 5024175
• 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: 01/06/2026
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown