MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-01-31 for ORAL CARE KIT,W/MOIST,PEROXIDE 12260 991096883 manufactured by Halyard Health.
[66216812]
The device history record for the reported lot number, m6228a601, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance. One sample was received. One sample was received with the package label. The sample was received inside a bio-hazard sample bag. The sample was disinfected inside the lab hood using caviwipes. The swab appeared in clean condition with no obvious visible signs of use. The swab stick was broken at approximately 3. 25" from the end. Under magnification, stress whitening was observed on the broken ends. Lateral white striations were also observed adjacent to the break. The swab sponge was securely attached to the stick. Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred. This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[66216813]
A single report was received that referenced five different incidences, which were associated with separate units, involving six different events. This is the fourth of six reports. Refer to 8030647-2017-00006 for the first event. Refer to 8030647-2017-00007 for the second event. Refer to 8030647-2017-00008 for the third event. Refer to 8030647-2017-00010 for the fifth event. Refer to 8030647-2017-00014 for the sixth event. It was reported that the oral swab sticks were breaking during use in patient's mouth's. Additional information was received on 07-jan-2017 stated, the customer had another broken swab that broke while in use with a patient which, this additional information brought the total number to six events. No injury reported. No additional information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030647-2017-00009 |
| MDR Report Key | 6291382 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-01-31 |
| Date of Report | 2017-01-02 |
| Date of Event | 2016-12-30 |
| Date Mfgr Received | 2017-01-02 |
| Device Manufacturer Date | 2016-08-15 |
| Date Added to Maude | 2017-01-31 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LISA CLARK |
| Manufacturer Street | 5405 WINDWARD PARKWAY |
| Manufacturer City | ALPHARETTA GA 30004 |
| Manufacturer Country | US |
| Manufacturer Postal | 30004 |
| Manufacturer Phone | 4704485444 |
| Manufacturer G1 | AVENT S DE RL DE CV |
| Manufacturer Street | CARRETERA INTERNACIONAL SALIDA NORTE NO. 1053 |
| Manufacturer City | MAGDALENA, CP 84160 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 84160 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORAL CARE KIT,W/MOIST,PEROXIDE |
| Generic Name | VAP ORAL CARE PRODUCTS |
| Product Code | KXF |
| Date Received | 2017-01-31 |
| Returned To Mfg | 2017-01-25 |
| Model Number | 12260 |
| Catalog Number | 991096883 |
| Lot Number | M6228A601 |
| Device Expiration Date | 2018-08-15 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HALYARD HEALTH |
| Manufacturer Address | 5405 WINDWARD PARKWAY ALPHARETTA GA 30004 US 30004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-31 |