MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. FIXED NEEDLE INSULIN SYRINGE; SYRINGE, PISTON

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 08/02/2019

Event Type  malfunction  

Event Description

Rn removed insulin syringe from packaging and noticed that there was an extra needle attached to the syringe on the side.Insulin syringe discarded by bedside rn but packaging sequestered with extra needle.

• Brand Name: FIXED NEEDLE INSULIN SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• MDR Report Key: 9103342
• MDR Text Key: 159602650
• Report Number: 9103342
• Device Sequence Number: 1
• Product Code: FMF
• 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: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 12410 DA