MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-04-23 for ADULT 8.0MM ET TUBE WITH SUBGLOTTIC SUCTIONING 13222 991013222 manufactured by Kimberly-clark Health Care.
[17991020]
Kimberly-clark received a report stating,? When respiratory was tending to the patient the [pilot] line was caught and disconnected. There was no injury, but the patient had to be reintubated. " the tube used on the patient was discarded; however a unopened sample was returned to kimberly-clark. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[18232738]
The device history record was reviewed and documented that the product lot reported in the incident met manufacturing specifications. One unopened sample device was returned. The sample was removed from the package and the pilot line was gently manipulated. The pilot line remained intact; unable to duplicate reported failure. 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 | 9611594-2014-00024 |
| MDR Report Key | 3768832 |
| Report Source | 07 |
| Date Received | 2014-04-23 |
| Date of Report | 2014-03-25 |
| Date Mfgr Received | 2014-03-25 |
| Date Added to Maude | 2014-06-17 |
| 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 8.0MM ET TUBE WITH SUBGLOTTIC SUCTIONING |
| Generic Name | ENDOTRACHEAL TUBE |
| Product Code | BSK |
| Date Received | 2014-04-23 |
| Returned To Mfg | 2014-04-09 |
| Model Number | 13222 |
| Catalog Number | 991013222 |
| Lot Number | AA3239V01 |
| Operator | RESPIRATORY THERAPIST |
| 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 | 2014-04-23 |