MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 3ML SALINE 3ML FILL; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number	306544
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material # 306544 batch # 4317284.I had a nurse bring me a 3 ml saline flush yesterday that she opened form the package and was about to use when she noticed a piece of what looks like the black rubber stopper floating in the saline.Small enough it could have been pushed out of the syringe into the line.Customer response received on 03-feb-25 1.Can you please provide an exact date of event the syringe was discovered on 01-29-2025.2.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.No patient harm, injury, complication or negative outcome occurred.The nurse was about to flush an iv when she saw the piece floating in the saline.
Additional Manufacturer Narrative
Pr (b)(4) follow up for device evaluation.It was reported a piece of the black rubber stopper was floating in the saline.To aid in the investigation, one sample with no packaging flow wrap and two photos were received for evaluation by our quality team.A visual inspection was performed, and there is a loose particle in the syringe that is 1/8" x 1/32".The particle has the same material composition as the rubber stopper.The rubber stopper in the syringe has no damages.The two photos provided show the sample received.No other defects or imperfections were observed.This defect could occur if a particle was left adhered to the stopper during the rubber stopper trimming process.A device history record review was completed for provided material number 306544, lot 4317284.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.The sample will be shown to associates for awareness.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.
Event or Problem Description
No additional information received.

• Brand Name: SYRINGE 3ML SALINE 3ML FILL
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• 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: 21313450
• Report Number: 1911916-2025-00085
• Device Sequence Number: 20870785
• Product Code: NGT
• UDI-Device Identifier: 30382903065449
• UDI-Public: (01)30382903065449(11)241112(17)271031(10)4317284
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K003553
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2025

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: 306544
• Device Lot Number: 4317284
• 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: 01/30/2025
• Supplement Date Received by Manufacturer: 02/09/2025
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown