MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2009-10-06 for 450 SAL EJECTOR 3283 8881450004 manufactured by Covidien.
[1219960]
It was reported to covidien that a customer had an issue with a saliva ejector. Customer states that the tip is falling off prior to use on a pt. Based on the initial report covidien suspected the user was damaging the product prior to use, and it was not a product malfunction. Based on the sample analysis and investigation results on (b) (6) 2009, we concluded that the reported incident, although a pt was not involved, could have been a product malfunction.
Patient Sequence No: 1, Text Type: D, B5
[8403886]
(b) (4). The units were manufactured on 01/07/2009. The device history record (dhr) was reviewed indicating that product was released accomplishing all quality standard requirements. There were no non-conforming issues reported during the production of this product for a similar condition as reported in this complaint. Prior to a lot's release, it must be deemed acceptable by passing visual, dimensional and functional inspections that are based on a valid sampling plan. The inspection plan of this product code includes the tube and tip bond test performed on a sampling basis for all lots. The specification for this test is that the bonding must withstand a minimum tension of 2 lbs. The data recorded on the dhr file for the bonding tension test was analyzed statistically and all samples passed the specification of 2 lbs minimum for the tip and tube bond strength. The manufacturing personnel of the saliva ejector assembly line and qc inspectors, as well as personnel from supporting departments were notified of this incident to make them aware of the potential implications of this type of product failure and to perceive the importance and repercussion of the complaint condition reported and to preclude recurrence. Seventy-nine unused samples were received at the plant for evaluation. After performing a visual inspection, the defective condition was confirmed in one sample. This tip is completely detached from the tube and residuals of solvent were observed in the edge of the tube in the sample. In the remaining samples that were tested, the tip was found attached to the tube. Thirty-one of these samples were tested for bond strength between tip and tube. The data from the testing was analyzed statistically and all samples passed the specification of 2 lbs minimum for the tip and tube bond strength. The root cause analysis indicates the defective condition reported by the customer was caused by the amount of solvent applied to the tube. It was not enough to maintain a strong attachment from the tip to the tube. From the condition observed in the defective sample, the solvent was not spread completely around the circumference of the tube; therefore, the tip was bonded to the tube only with a small portion of it and not the entire circumference. The amount of solvent applied depends on the spraying time and pressure, which are parameters that the operator is able to modify. If the moving arm that pushes the tip onto the tube is misaligned with respect to the cavity where the tube is placed, it can cause a weak assembly of the tip. The assembly machine features a discarding system of tubes without tips. There is a sensor that must detect the presence of the tip on the tube. If the assembly does not have a tip, the sensor trigger a signal to activate a gripper that grasps the tube without a tip and discards it. The discarding system of tubes without a tip was disabled. To correct and prevent the problem, a design of experiments (doe) of the solvent application conditions will be performed to determine the optimal operation window for the parameters of spraying time and spraying pressure. This will allow control to the assembly operation of the process, assuring a sufficient spread of solvent on the entire circumference of the tube at the edge where the tip is bonded. The revolver where the tube is placed for the tip assembly will be re-aligned with the moving arm that pushes the tip, to assure that the arm is aligned with the cavity of the tube. The discarding system detecting tubes without tips will be activated. The sensor that detects the presence of the tip will be repaired and the gripper that grasps the tubes without tips will be activated. The action palin and subsequent follow-up will be documented. We will continue to trend for this defect and take further action as necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2009-00032 |
| MDR Report Key | 1508548 |
| Report Source | 05,06 |
| Date Received | 2009-10-06 |
| Date of Report | 2009-09-17 |
| Report Date | 2009-09-17 |
| Date Reported to Mfgr | 2009-09-17 |
| Date Mfgr Received | 2009-09-17 |
| Device Manufacturer Date | 2009-01-01 |
| Date Added to Maude | 2010-04-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | ELAINE BISHOP |
| Manufacturer Street | 15 HAMPSHIRE ST |
| Manufacturer City | MANFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524686 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL |
| Manufacturer City | TIJUANA 92173 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 92173 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 450 SAL EJECTOR 3283 |
| Generic Name | SALIVA EJECTOR |
| Product Code | DYN |
| Date Received | 2009-10-06 |
| Returned To Mfg | 2009-07-16 |
| Model Number | 8881450004 |
| Catalog Number | 8881450004 |
| Lot Number | 900703264 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | CALLE 9 SUR NO. 125 CUIDAD TIJUANA 92173 MX 92173 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-10-06 |