MAUDE Adverse Event Report: FRESENIUS KABI LOVENOX NOVAPLUS; SYRINGE

Model Number 40MG PRE-FILLED SYRINGE

Device Problems Loose or Intermittent Connection (1371); Device Dislodged or Dislocated (2923)

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

Event Date 05/16/2018

Event Type  malfunction  

Event Description

Nurse was administering lovenox shot to patient, retracted the needle into cassette, she then stated as the plunger was retracting the spring came loose and the needle of the lovenox injection shot out of the back of the injection syringe and catapulted to the floor.Very lucky the nurse did not get stabbed with the needle, patient has (b)(6).Pharmacist was notified.Packaging of this needle was not kept.

• Brand Name: LOVENOX NOVAPLUS
• Type of Device: SYRINGE
• Manufacturer (Section D): FRESENIUS KABI; 3 corporate drive; lake zurich IL 60047
• MDR Report Key: 7569106
• MDR Text Key: 110076050
• Report Number: 7569106
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/16/2018

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 Operator: Nurse
• Device Model Number: 40MG PRE-FILLED SYRINGE
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/16/2018
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR