MAUDE Adverse Event Report: COVIDIEN MONOJECT SAFETY NDL 30 X 1/2; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	1183005
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that the nurse practitioner was injecting the patient with botox when the needle attached to the botox syringe malfunctioned, causing botox to squirt out around the hub of the needle, resulting in the loss of botox and botox going to patient's eye.Nursing contacted the pharmacy and optometry and washed out patient's eye per their recommendation.An extra 50 units of botox had to be drawn up to replace the botox that was lost.25 units were lost.Additional information provided on (b)(6) 2021 stated that the patient's eye was washed out with saline and there was no harm to the patient.

• Brand Name: MONOJECT SAFETY NDL 30 X 1/2
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 12165794
• Report Number: 1282497-2021-10493
• Device Sequence Number: 3820579
• Product Code: FMI
• UDI-Device Identifier: 10884521544789
• UDI-Public: 10884521544789
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/14/2021

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
• Operator of Device: Health Professional
• Device Model Number: 1183005
• Device Catalogue Number: 1183005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 07/14/2021
• Patient Sequence Number: 1