MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-04-25 for ADULT 8.0MM ET TUBE WITH SUBGLOTTIC SUCTIONING 13222 991013222 manufactured by Kimberly-clark Health Care.
[4436144]
Kimberly-clark received a report from the united kingdom stating, "when using the kc subglottic tube the pilot cuff detached from the tube, causing the cuff to deflate. This meant the patient had to be reintubated (without any apparent harm). This appeared to be spontaneous and not related to patient biting the tube. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11879818]
We are unable to review the device history record as no lot number was provided for the device involved in this reported event. One sample device was returned. Physical appearance of sample shows pilot line was detached at the pilot line tube connection. Information from this incident will be included in our product complaint and mdr trend reporting systems. Ongoing analysis of trend information is used to identify the need for additional investigations.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611594-2014-00036 |
| MDR Report Key | 3773987 |
| Report Source | 07 |
| Date Received | 2014-04-25 |
| Date of Report | 2014-04-01 |
| Date of Event | 2014-03-30 |
| Date Mfgr Received | 2014-03-31 |
| Date Added to Maude | 2014-06-18 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RA/QA AE COORDINATOR |
| Manufacturer Street | 1400 HOLCOMB BRIDGE ROAD |
| Manufacturer City | ROSWELL GA 30076 |
| Manufacturer Country | US |
| Manufacturer Postal | 30076 |
| Manufacturer G1 | NOGALES 1 |
| Manufacturer Street | CARRETERA INTN'L SALIDA NORTE #1053 |
| Manufacturer City | MAGDALENA SONORA 84160 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 84160 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADULT 8.0MM ET TUBE WITH SUBGLOTTIC SUCTIONING |
| Generic Name | ENDOTRACHEAL TUBE |
| Product Code | BSK |
| Date Received | 2014-04-25 |
| Returned To Mfg | 2014-04-10 |
| Model Number | 13222 |
| Catalog Number | 991013222 |
| Lot Number | ANP |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | KIMBERLY-CLARK HEALTH CARE |
| Manufacturer Address | 1400 HOLCOMB BRIDGE ROAD ROSWELL GA 30076 US 30076 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-25 |