MAUDE Adverse Event Report: BECTON-DICKINSON AND COMPANY LUER SLIP TIP SYRINGE STERILE, SINGLE USE, 1 ML; SYRINGE, PISTON

Model Number 309659

Device Problems Contamination (1120); Material Discolored (1170)

Patient Problem Insufficient Information (4580)

Event Date 03/21/2023

Event Type  malfunction  

Event Description

I noticed visible contamination on an unopened sterile bd 1 ml tuberculin slip-tip syringe (ref (b)(4)).The lot number is 2203500.Our lab uses these syringes in prokaryotic microbial research with no direct human health applications, but i felt that it would be important to report this.I can't ascertain whether the residue is only on the outside of the syringe or actually inside the tip without opening the sterile wrapper, which i didn't think i should do without reporting this first.All i can say with certainty is that the discoloration is on the syringe itself, not just the inside of the packaging.

• Brand Name: LUER SLIP TIP SYRINGE STERILE, SINGLE USE, 1 ML
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON-DICKINSON AND COMPANY
• MDR Report Key: 16618248
• MDR Text Key: 312137272
• Report Number: MW5115971
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/22/2023

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
• Device Model Number: 309659
• Device Lot Number: 2203500
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2023
• Patient Sequence Number: 1