MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 10ML SHORT PR SALINE 10ML FILL; SALINE, VASCULAR ACCESS FLUSH

Catalog Number	306499
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation: a report was received regarding sterile saline syringes with malfunctioning plungers.To support the investigation, one empty syringe sample¿lacking a packaging flow wrap and tip cap¿was submitted for evaluation by the quality team.A visual inspection was conducted using 10x magnification.The syringe¿s plunger rod and barrel showed no signs of damage or cracking.No defects or imperfections were observed.The sample was subsequently tested for sustaining force, defined as the force applied to the plunger rod during downward movement to expel the saline solution.The test results were within specification.A device history record (dhr) review was completed for material number 306499, lot 5077095.The review found no quality issues during production that could be linked to the reported condition.No related quality notifications were identified.All manufacturing processes and final inspections were performed in accordance with specification requirements.To date, no similar incidents have been reported for this lot.Based on the investigation and analysis of the returned sample, the reported issue could not be confirmed.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
Description: it was reported by customer that sterile saline syringes with malfunctioning plungers.Verbatim: there was an ir placed a few weeks back about sterile saline syringes with malfunctioning plungers.At that time, i sent down the product.We do have another syringe that had the same issue this morning and i have that product as well.The clear package that the saline flushes don¿t have anything on the package.Additional information the nurse was using a sterile saline 10cc flush to draw back blood from a central line after flushing the line with water.As she was pulling back, she felt a lot of pressure, and then suddenly the black piece of rubber that attaches to the plunger of the syringe came off and the suction mechanism of drawing back was disengaged.There was no harm to the patient.I am unsure of the date of the last event, i apologize.It was not reported to bd but it was a similar situation where the suction mechanism was disengaged when drawing back with the plunger to get blood off a line.

• Brand Name: SYRINGE 10ML SHORT PR SALINE 10ML FILL
• Common Device Name: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 22412803
• Report Number: 1911916-2025-00498
• Device Sequence Number: 9977842
• Product Code: NGT
• UDI-Device Identifier: 00382903064991
• UDI-Public: (01)00382903064991
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K161552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2025

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: Health Professional
• Device Catalogue Number: 306499
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 07/07/2025
• 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