MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-04-21 for ADULT 7.5MM ET TUBE WITH SUBGLOTTIC SUCTIONING 13221 991013221 manufactured by Kimberly-clark Health Care.
[4416350]
Kimberly-clark received a report stating,? Customer reported that the pilot line disconnected from the endotracheal tube. This occurred when the patient moved around and the line got caught on something and detached from the tube. There was no injury, but the patient had to be reintubated. The tube used on the patient was discarded. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11719900]
We are unable to review the device history record as no lot number was provided for the device involved in this reported event. The device was not returned to kimberly-clark for evaluation, therefore we are unable to determine a root cause for the reported event. 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. Device not returned by customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611594-2014-00023 |
| MDR Report Key | 3762521 |
| Report Source | 07 |
| Date Received | 2014-04-21 |
| Date of Report | 2014-03-25 |
| Date Mfgr Received | 2014-03-25 |
| Date Added to Maude | 2014-06-13 |
| 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 | 2014-04-21 |
| Model Number | 13221 |
| Catalog Number | 991013221 |
| Lot Number | ANP |
| Operator | RESPIRATORY THERAPIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2014-04-21 |