MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-02 for MEDLINE CHG 0.12% ORAL RINNSE KIT manufactured by Medline Industries, Inc..
[122800732]
Medline chg 0. 12% oral rinse oral care kit suction/swab broke off at adaptor site, plastic snapped completely disconnecting the suction adaptor from the swab. This occurred during mouth care. Attempted a second swab and the same thing occurred. No patient harm occurred, this did not occur with the tooth brush swab.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080304 |
| MDR Report Key | 7929910 |
| Date Received | 2018-10-02 |
| Date of Report | 2018-09-28 |
| Date of Event | 2018-09-28 |
| Date Added to Maude | 2018-10-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDLINE CHG 0.12% ORAL RINNSE KIT |
| Generic Name | ORAL SUCTION SWAB/APPLICATOR ABSORBED TIPPED STERILE |
| Product Code | KXG |
| Date Received | 2018-10-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-10-02 |