MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-21 for 3612 LITE GLOVE 2X80 31140257 manufactured by Covidien.
[26601733]
An investigation is currently under way; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[26601734]
It was reported to covidien on (b)(6) 2015 that a customer had an issue with a lite glove. The customer reports the material of several lite gloves ripped open when putting them over the light handle. The lite gloves are too small. The issue was noticed before the patient was in the operating room. There was no person injured.
Patient Sequence No: 1, Text Type: D, B5
[32924890]
The device history record (dhr) was reviewed, and no abnormal process condition was present during the manufacturing of the product that could have led to the reported condition. The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process. Two cases with unused product and lot number 5145101964x were received for evaluation. The samples were visually inspected according to the product specifications and none of the samples demonstrated the reported condition. The reported condition could not be confirmed however, based on previous evaluations on samples reported with a similar condition the potential root cause that was determined for this issue was a problem that occurred during the forming process in which the forming tool reaches a high temperature. Due to properties of the material, the heat is concentrated at the point of contact with the film and not dissipated throughout the rest of the tooling therefore it does not balance out. This may cause the film to overheat and could potentially affect the strength of the material. As a corrective action the material used for the plug assists was changed; the difference in this change is its properties, the heat stabilized around the tooling (not only the contact point with the film) having a lower impact on the film forming process. An engineering test request (etr) was performed to determine the best temperatures to form the lite glove with the new forming tool using the newer, improved material. After the etr was approved, validation was performing to confirm the proposed parameters and ensure the quality of the product. A formal corrective and preventative action was implemented as a result. If additional information is received warranting further analysis, the investigation will be resumed. This complaint will be used for tracking and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2015-00090 |
| MDR Report Key | 5090672 |
| Date Received | 2015-09-21 |
| Date of Report | 2015-09-04 |
| Date Mfgr Received | 2015-12-08 |
| Device Manufacturer Date | 2015-06-01 |
| Date Added to Maude | 2015-09-21 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | THOM MCNAMARA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524811 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL |
| Manufacturer City | TIJUANA 22500 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3612 LITE GLOVE 2X80 |
| Generic Name | LITE GLOVE |
| Product Code | FQP |
| Date Received | 2015-09-21 |
| Model Number | 31140257 |
| Catalog Number | 31140257 |
| Lot Number | 5145101964X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-21 |