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

Model Number 8881540133

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 01/29/2019

Event Type  malfunction  

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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer states the plunger got stuck and an extreme amount of pressure had to be applied in order to make the medication pass through.In addition, the customer stated anecdotally that this had happened several times however they could not provide any further information regarding these events.

Manufacturer Narrative

A review of the device history record (dhr) for lot no.825713 indicated the product was released meeting all quality standards.All dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.Maintenance records (both corrective and preventive) and calibration records showed no issues related to the reported condition.All scheduled maintenance and calibration activities were completed.There were no process or material changes related to the reported condition for this product.A review of the machine setup was conducted and revealed no issues.The equipment was reviewed for malfunctions or issues that could have contributed to the reported condition, but no such issues were observed during the review.A review of the entire dhr showed no manufacturing or inspection anomalies.Requests were made for sample return.No product/sample was received for evaluation.No additional information, pictures or videos were received.Therefore, a comprehensive investigation was unable to be conducted.The reported customer complaint could not be confirmed.A root cause could not be determined.This complaint will be used for tracking and trending purposes.

• Brand Name: 3ML SMARTIP MED-PREP CANNULA
• Type of Device: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 8312225
• MDR Text Key: 135216936
• Report Number: 1017768-2019-00566
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881540133
• Device Catalogue Number: 8881540133
• Device Lot Number: 825713
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/30/2019
• Patient Sequence Number: 1