MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PROTECTIV PLUS; CATHETER, SHORT TERM, INTRAVASCULAR

Model Number 3065

Device Problem Failure to Advance (2524)

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

Event Date 06/11/2019

Event Type  malfunction  

Event Description

Several of our smiths medical 18g x 1 1/4 needles (mfg# 3065) are not advancing once the needle has been inserted.All are the same lot # 3804620.Samples have been saved.This lot has been pulled.

• Brand Name: PROTECTIV PLUS
• Type of Device: CATHETER, SHORT TERM, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• MDR Report Key: 8703494
• MDR Text Key: 148158288
• Report Number: 8703494
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3065
• Device Catalogue Number: 3065
• Device Lot Number: 3804620
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1