MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other,use report with the FDA on 2017-02-10 for ORAL CARE KIT,W/MOIST,PEROXIDE 12260 991096883 manufactured by Halyard Health.
[67279273]
The sample was received and evaluated. 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 appears 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. Root has not been determined and the investigation is ongoing. The device history record for the lot number, m6228a601, involved in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements. 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(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[67279274]
It was reported that an oral swab broke while in use with a patient. Additional information was received on 24-jan-2017 that states, "while using an oral swab, the stick broke. It snapped in half with little pressure being applied. " additional information was received on 31-jan-2017 that states, the two issues reported on (b)(6) 2017 are the same incident and only one should be reported for (b)(6) 2017. The additional email was provided to give more detailed information and there was only one patient involved. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
[71609399]
Pro code: -kxf, mfg site for devices: (b)(4). All information reasonably known as of 31mar2017 has been included in this health authority report. Should additional information be obtained, a follow-up health authority report will be provided. The information provided by halyard health represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health. 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
| Report Number | 8030647-2017-00026 |
| MDR Report Key | 6322094 |
| Report Source | HEALTH PROFESSIONAL,OTHER,USE |
| Date Received | 2017-02-10 |
| Date of Report | 2017-03-14 |
| Date of Event | 2017-01-17 |
| Date Mfgr Received | 2017-03-14 |
| Device Manufacturer Date | 2016-08-15 |
| Date Added to Maude | 2017-02-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | CP |
| Manufacturer Country | MX |
| 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 | 2017-02-10 |
| 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 Age | DA |
| 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 | 2017-02-10 |