MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-11 for SUCT CTH KIT W/O SOL SFTY-VAC 10FR 37024 manufactured by Kenmex.
[40418010]
(b)(4). An investigation is currently under way. Upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[40418011]
It was reported to covidien on (b)(6) 2013 that a customer had an issue with a gauze sponge. The customer reports: suction catheters used for suctioning mucus when a trach is already in place. The suction catheters are occluded and not suctioning correctly. No air flow is going through to produce suctioning.
Patient Sequence No: 1, Text Type: D, B5
[45757666]
A review of the device history record could not be conducted because a lot number was not provided. Manufacturing records are routinely reviewed prior to the release of product to ensure process and product are according the specifications; no findings related to the reported condition were reported. There were no samples returned for this complaint. The complaint shall be reopened if a sample is received. Because the sample has not been received the failure mode could not be confirmed; therefore, the root cause was not identified. As part of the injection molding process the melted resin flows from the machine barrel through the mold manifold and after that filling the mold cavities. During the natural flow of the resin, vent lines are part of the mold design to facilitate the air flow through the injection molding process. Some vent lines could be blocked or inaccessible and that could generate the entrapment of air causing the reported condition. A production notification was sent out to all personnel to ensure that they are aware on the condition reported by the customer and the inspection plan for the valves was moved to tight. 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 | 9612030-2016-00106 |
| MDR Report Key | 5494635 |
| Date Received | 2016-03-11 |
| Date of Report | 2013-07-25 |
| Date Mfgr Received | 2013-07-25 |
| Date Added to Maude | 2016-03-11 |
| 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 ST |
| 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 |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUCT CTH KIT W/O SOL SFTY-VAC 10FR |
| Generic Name | SUCTION CATHETER |
| Product Code | OFR |
| Date Received | 2016-03-11 |
| Model Number | 37024 |
| Catalog Number | 37024 |
| Lot Number | ASKU |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KENMEX |
| Manufacturer Address | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-11 |