MAUDE Adverse Event Report: BD BD 30 ML SYRINGE- SERINGUE LUER-LOK TIP EMBOUT BD LUER-LOK; SYRINGE, PISTON

Model Number 302832

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 03/30/2022

Event Type  malfunction  

Event Description

Found bd luer lock sterile syringe like this from the package.Staff noticed it before starting to compound something with it.It was a greenish/brown wet looking substance along the inside of the luer lock sterile syringe.Manufactured by bd.Fda safety report id # (b)(4).

• Brand Name: BD 30 ML SYRINGE- SERINGUE LUER-LOK TIP EMBOUT BD LUER-LOK
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BD
• MDR Report Key: 13995601
• MDR Text Key: 288619071
• Report Number: MW5108725
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 302832
• Device Catalogue Number: 302832
• Device Lot Number: 1363310
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1