MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-04-22 for ENDOTRACHEAL TUBE PEDIATRIC ORAL/NASAL MAGILL 3.5MM 35112 991035112 manufactured by Kimberly-clark Health Care.
[4553718]
Kimberly-clark received a report stating,? The nurse reported the pilot line was pulled off the endotracheal tube. The cuff deflated but the patient was not intubated. At the time of the event, the device remained in use but was eventually returned to kimberly-clark. " (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11853610]
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 was returned. The endotracheal tube is kinked and exhibits a wavy appearance. The pilot line was detached from the sample upon receipt. The detached pilot line was viewed under magnification and a layer of adhesive was visible on the pilot line at the point in which it attaches to the endotracheal tube.. 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 | 1033422-2014-00012 |
| MDR Report Key | 3762774 |
| Report Source | 07 |
| Date Received | 2014-04-22 |
| Date of Report | 2014-03-24 |
| Date of Event | 2014-03-18 |
| Date Mfgr Received | 2014-03-24 |
| Date Added to Maude | 2014-06-16 |
| 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 | THAILAND SSCT |
| Manufacturer Country | TH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOTRACHEAL TUBE PEDIATRIC ORAL/NASAL MAGILL 3.5MM |
| Generic Name | ENDOTRACHEAL TUBE |
| Product Code | BSK |
| Date Received | 2014-04-22 |
| Returned To Mfg | 2014-04-11 |
| Model Number | 35112 |
| Catalog Number | 991035112 |
| Lot Number | ANP |
| Operator | NURSE |
| 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 | 2014-04-22 |