MAUDE Adverse Event Report: COVIDIEN 3ML SMARTIP MED-PREP CANNULA; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	8881540133
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer reported that when putting the device into a vial and trying to draw up the medication, the medication squirts out the side of the device.
Additional Manufacturer Narrative
The lot number was provided with the sample returned for the evaluation.The device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A review of maintenance records (both corrective and preventive) and calibration records were reviewed and there were no issues.All scheduled maintenance and calibration activities were completed.There were no related process or material changes related to the reported condition for this product or describe changes that occurred.A review of the machine setup was conducted, and no issue were observed.There was one sample returned for the evaluation.The leak was identified between the connection points to the sheath, commonly referred to as the ¿ears¿ of the hub.This portion of the hub is the area with the least amount of plastic thickness.Therefore, the reported condition is confirmed.Based on this evaluation, the most likely root cause could occur within the molding process due to a reduction of volume entering into the cavity making the hub.As previously noted, an issue was identified within the generation of one the shop orders via a short shot which is also related to a lack of plastic volume.Prior to a lot¿s release, the lot must be deemed acceptable by-passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.Specifically, the lot met all defined acceptance requirements and was released.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: 3ML SMARTIP MED-PREP CANNULA
• Common Device Name: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 9823356
• Report Number: 1017768-2020-00813
• Device Sequence Number: 3037169
• Product Code: GEA
• UDI-Device Identifier: 10884521082946
• UDI-Public: 10884521082946
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 8881540133
• Device Catalogue Number: 8881540133
• Device Lot Number: 932237
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 05/04/2020
• Patient Sequence Number: 1