MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-09-04 for 3612 LITE GLOVE 31140257 3140257 manufactured by Covidien.
[4837083]
It was reported to covidien on (b)(4) 2014 that a customer had an issue with a lite glove. The customer reports there was some tearing at the seams when placing the glove on the light handle. This was repeated with a different light glove with the same results. The customer further reports that the pt was in the room and the pt was treated with prophylactic antibiotics.
Patient Sequence No: 1, Text Type: D, B5
[12371003]
Submit date on: (b)(4) 2014. An investigation is currently underway. Upon completion, the results will be forwarded
Patient Sequence No: 1, Text Type: N, H10
[28688614]
The lot number was provided and the device history record was reviewed indicating that the product was released accomplishing all quality standard requirements. There were no non-conforming issues in relation to the failure reported. No samples were received by covidien for evaluation. Because a sample was not returned, we were unable to perform a thorough follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis. However, based on previous investigations reported with similar failure modes, the reported issue could not be re-produced and is not detected during the manufacturing process. The following variables which could be a contributor were found during the molding process review: lack of edges, misalignment and mismatch on the knives (which could cause the lite glove to not separate properly from the film), two ceramic lamps in the furnace require replacement for proper heating of the film. As an immediate corrective action, awareness training was performed to all personnel to ensure they are aware of this issue, and to enhance awareness during the visual inspection process. The acceptable quality level for the sub-assembly release was moved from normal to tighten in the thermo line. A sample board was made to help production personnel improve awareness in the detection process (pick and place multivac line) and to also notify manufacturing personnel about discarding non-conforming lite gloves. As a corrective action, the following activities have been completed: replacement of 2 ceramic lamps, the knives have been adjusted, aligned and sharpened. As a preventive action, the processes will be updated to reflect the failure mode reported and the reaction plan to mitigate the issue reported. In addition, the maintenance procedure has been updated to include the thermography frequency.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2014-00051 |
| MDR Report Key | 4115806 |
| Report Source | 05,06,07 |
| Date Received | 2014-09-04 |
| Date of Report | 2014-08-08 |
| Date Mfgr Received | 2014-11-07 |
| Device Manufacturer Date | 2014-06-10 |
| Date Added to Maude | 2014-10-01 |
| 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 | 0 |
| Manufacturer Contact | JANICE NEVIUS |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616283 |
| 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 | 3612 LITE GLOVE |
| Generic Name | LITE GLOVE |
| Product Code | FQP |
| Date Received | 2014-09-04 |
| Model Number | 31140257 |
| Catalog Number | 3140257 |
| Lot Number | 4147103364X |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL TIJUANA 92173 MX 92173 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-09-04 |