MAUDE Adverse Event Report: BD BD 3 ML SYRINGE; SYRINGE, PISTON

Catalog Number 309578

Device Problems Difficult to Remove (1528); Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/23/2019

Event Type  malfunction  

Event Description

Contaminant in bd 3 ml syringe, lot #9140817, item#(b)(4).There was no difficulty in drawing the medication into the syringe; however, when the nurse attempted to remove the needle from the syringe, she was unable to do so.The medical director was in the bay, and he was able to remove the needle.When he did so, he noted a foreign contaminant in the syringe at the intersection of the syringe contacting the hub of the needle.All syringes from the above-noted lot were immediately removed, and the bd rep was contacted.The syringe was taken to our lab director.Viewed under the microscope, the contaminant did not appear to be fungal.The lab director, using a sterile needle, removed a small portion of the contaminant and placed it on blood agar to culture.At 24-hours, it has not grown anything.It will be observed another 24 hours.Fda safety report id# (b)(4).

• Brand Name: BD 3 ML SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BD
• MDR Report Key: 9245696
• MDR Text Key: 164325003
• Report Number: MW5090715
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 309578
• Device Lot Number: 9140817
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1