MAUDE Adverse Event Report: COVIDIEN BLUNT CANNULA 19G X 1 1/2 RP; CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number 8881202355

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/19/2019

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.

Event Description

The customer reported that there were lose yellow particles from the housing of the needle that transferred threads onto the needle.

Manufacturer Narrative

Submit date: on 2-mar-2020.The following field was updated: section d4, lot number was updated from blank to 915425.

Manufacturer Narrative

H 3 evaluation summary: the device history record (dhr) for the reported lot indicates zero issues were found in visual and physical samples inspected from the lot.There were no nonconformance reports (ncr) issued against this lot.A review of the entire dhr showed no manufacturing or inspection anomalies.Pictures were provided with the complaint.The pictures were visually inspected, and two caps show signs of melted plastic coming from the heat stake of the cap.These particles that are attached to the cap is melted plastic coming from the cartridge.This melted plastic is normal within the manufacturing process as is needed for the cartridge to get attached to the cap.A second picture shows a needle with some string/flash of plastic coming from the heat seal.This could be caused by the heat seal debosser being too hot.The string of plastic does not have any contact with the needle that is securely enclosed by the cap and cartridge.The instructions for use (ifu) indicate that plastic particles could be expected when opening the needle and warns the user.There was one sample returned with this complaint.The sample was visually inspected, and the needle had an appropriate heat seal.There are no indications of plastic protruding from the heat seal.There were no signs of contamination or threads on the needle.The reported condition could not be confirmed.There were no manufacturing issues related to the complaint issued for this lot and a specific root cause could not be determined based on available information.There¿s no indication of a systemic issue with the product or process, so a corrective and preventative action (capa) will not be issued at this time.This information will be utilized for trending purposes to determine the need for corrective actions.

Manufacturer Narrative

The device history record (dhr) was reviewed, and the shop orders indicate that product and specification requirements were met with no non-conforming product identified relating to this customer report.There was one opened, unused sample returned with this complaint.The sample was visually inspected, and the needle had an appropriate heat seal.There are no indications of plastic protruding from the heat seal.The reported condition could not be confirmed.Based on the sample analysis, the condition reported from the customer could not be confirmed.The ¿particles¿ attached to the cap is melted plastic coming from the cartridge.This melted plastic is normal within the manufacturing process and the design of the device as is needed for the cartridge to attach to the cap.In addition, per the instructions for use (ifu) included in the unit¿s box, it states ¿to open package, align heat stake downward, away from face (eyes), body and patient.Break tamper-evident stake by twisting the cap or by applying a downward snap.¿ the instructions indicate that plastic particles could be expected when opening the needle and warns the user while is being opened.Though the manufacturing process, acceptable quality level (aql) sampling is being performed and according to the dhr review, it meets aql with zero defects in the visual inspection.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, samples are inspected for poor workmanship, contamination and incorrect assembly.The lot met all defined acceptance requirements and was released.There were no manufacturing issues related to the complaint issued for this lot and a specific root cause could not be determined based on available information.There¿s no indication of a systemic issue with the product or process, so a corrective/preventative action (capa) will not be issued at this time.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: BLUNT CANNULA 19G X 1 1/2 RP
• Type of Device: CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 9354258
• MDR Text Key: 167413675
• Report Number: 1017768-2019-00738
• Device Sequence Number: 1
• Product Code: GEA
• UDI-Device Identifier: 10884521012509
• UDI-Public: 10884521012509
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881202355
• Device Catalogue Number: 8881202355
• Device Lot Number: 915425
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/19/2019
• Patient Sequence Number: 1