MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-04-07 for ADULT 7.5MM ET TUBE WITH SUBGLOTTIC SUCTIONING 13221 991013221 manufactured by Kimberly-clark Health Care.
[20785326]
Kimberly-clark received a report stating, "these tubes were placed and the cuff leaked and would not hold air as soon as inflated. This happened to two patients in the er and both had to be re-intubated. This patient had to be re-intubated. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[20870745]
We are unable to review the device history record as no lot number was provided for the device involved in this reported event. Two samples were returned. No original packaging was returned with the two samples. The balloon on the 7. 5 microcuff tube sample is completely ruptured. The balloon material was viewed under magnification and no anomalies could be identified as the point of origin for the rupture. The balloon on the 8. 0 microcuff tube sample was inflated under water and bubbles were observed coming from the proximal collar area of the balloon. 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 | 9611594-2014-00022 |
| MDR Report Key | 3732473 |
| Report Source | 07 |
| Date Received | 2014-04-07 |
| Date of Report | 2014-03-10 |
| Date of Event | 2014-03-08 |
| Date Mfgr Received | 2014-03-10 |
| Date Added to Maude | 2014-06-03 |
| 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 Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADULT 7.5MM ET TUBE WITH SUBGLOTTIC SUCTIONING |
| Generic Name | ENDOTRACHEAL TUBE |
| Product Code | BSK |
| Date Received | 2014-04-07 |
| Returned To Mfg | 2014-03-17 |
| Model Number | 13221 |
| Catalog Number | 991013221 |
| 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 | 2014-04-07 |