MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD 30ML SYRINGE, LUER-LOK TIP; SYRINGE, PISTON

Catalog Number 305618

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/14/2020

Event Type  malfunction  

Event Description

Bd luer-lok tip 30 ml syringes observed to have leaking of compounded sterile product around the tip of the plunger.265 30ml syringes were leaking and were discarded.Fda safety report id # (b)(4).

• Brand Name: BD 30ML SYRINGE, LUER-LOK TIP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); franklin lakes NJ 07417
• MDR Report Key: 10483137
• MDR Text Key: 205532686
• Report Number: MW5096387
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 305618
• Device Lot Number: 0065656
• 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