MAUDE Adverse Event Report: COVIDIEN MONOJECT SAFETY NEEDLE 23 X 1 1/2; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	1182315
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/17/2019
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 stated the needle fell off the syringe as they were moving it from the patient to the kidney dish.Due to the weight of the safety cover, it fell with the needle facing upwards.A staff member attempted to cover the needle and suffered a sharps injury to the thumb in the process.The needle was disposed of as per sharps disposal process.
Event or Problem Description
The customer stated the needle fell off the syringe as they were moving it from the patient to the kidney dish.Due to the weight of the safety cover, it fell with the needle facing upwards.A staff member attempted to cover the needle and suffered a sharps injury to the thumb in the process.The needle was disposed of as per sharps disposal process.Additional information provided by the customer stated the customer has completed their internal investigation into the incident.On reflection, the injured colleague feels that it is likely that she hadn¿t constructed the syringe properly and this was the cause of the failure.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Samples were not received for evaluation, as a result we were unable to confirm the reported issue and determine a definitive root cause root cause.If the sample is received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.A visual evaluation was completed on fifty pieces of archived samples with lot number 16030710 and no abnormalities were detected.Ten of the archived samples were randomly selected and a simulation was completed to activate the protect arms of the products.There were no issues observed during this process.After the simulation was complete, all the protective arms of those activated products covered the needles.No exposed needles tips were observed, and no injuries occurred during this process.A review of all available information and the results of the investigation indicate the most likely root cause of this incident was user error.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.

• Brand Name: MONOJECT SAFETY NEEDLE 23 X 1 1/2
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8640224
• Report Number: 1282497-2019-08476
• Device Sequence Number: 1655440
• Product Code: FMI
• UDI-Device Identifier: 10884521544666
• UDI-Public: 10884521544666
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 1182315
• Device Catalogue Number: 1182315
• Device Lot Number: 16030710
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 11/13/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other