MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-05-06 for @TRAY, TRACHEOSTOMY, BASIC, 4 GAU DYND40582 manufactured by Medline Industries, Inc..
[16502147]
It was reported the incident occurred during trach care for a male resident. The clinician reported that a piece of the swab broke off in the inner cannula. It was unknown how much pressure was being applied by the clinician. The customer had no respiratory distress. The tip was removed from the inner cannula without further incident. It did not occlude the airway. Inserting the cotton tip into the opening of the trach/inner cannula is contraindicated. The labeling on the trach care tray states: "caution" only use cotton tip applicators for cleaning around tracheostomy incision. Do not use to clean lumen of indwelling tube which could be dangerous and result in airway obstruction. "
Patient Sequence No: 1, Text Type: N, H10
[16638458]
While providing trach care to one of their residents, the tip of the plastic swab broke off and went into the trach. The tip was removed from inside the inner cannula and the resident was reported to be doing fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2009-00030 |
| MDR Report Key | 1376628 |
| Report Source | 06 |
| Date Received | 2009-05-06 |
| Date of Report | 2009-05-01 |
| Date of Event | 2009-04-02 |
| Date Facility Aware | 2009-04-03 |
| Date Added to Maude | 2010-04-10 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | LARA SIMMONS |
| Manufacturer Street | ONE MEDLINE PL. |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8478372759 |
| Manufacturer G1 | MEDLINE INDUSTRIES, INC. |
| Manufacturer Street | ONE MEDLINE PL. |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60060 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | @TRAY, TRACHEOSTOMY, BASIC, 4 GAU |
| Generic Name | NONE |
| Product Code | LRQ |
| Date Received | 2009-05-06 |
| Model Number | DYND40582 |
| Lot Number | 08LA0035 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-05-06 |