MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 10ML LL S/C 200; SYRINGE, PISTON

Catalog Number 302995

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2024

Event Type  Injury  

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

Material #: 302995, batch#: 3354727.It was reported by customer that when pulled back on plunger to draw blood heard a pop and noted the plunger broke (the plastic got disconnected from the rubber stopper).When removed it from the patient¿s line writer noted clear liquid in the syringe near the black rubber piece that is still suctioned to the syringe opening.Lot# 3354727.Additional information: date of event: 16 feb 2024.Was there any leakage due to the damage? there was no leakage noted from the patient's central line and their line was not affected by the incident.As stated in the report, there was clear fluid noted in the syringe when the rubber stopper and the plunger broke; i don't know if this was fluid that was already in the syringe prior to attaching it to the patient or if it was fluid from the patient's central line when attempting to use the syringe.How was treatment completed for customer? a new syringe was collected from the supply room to complete blood sampling.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Please include treatment/intervention provided and the outcome: none.Please confirm whether there was any patient impact: the syringe was attached to a patient's central line when the incident occurred but no impact was noted to the patient and the central line had no change noted after the incident.Can you please provide more details and describe how the product is damaged? the plunger disconnected from the rubber stopper.

• Brand Name: SYRINGE 10ML LL S/C 200
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18787639
• MDR Text Key: 336312666
• Report Number: 1911916-2024-00149
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 302995
• Device Lot Number: 3354727
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1