MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-13 for EXTENDED CARE SUCTION SWAB KIT WITH BIOTENE (DENTIP ORAL SWAB) MDS096550 manufactured by Medline Industries.
[94697483]
Patient Sequence No: 1, Text Type: N, H10
[94697484]
Oral swab stick was used to complete oral care on patient. When rn removed the swab, the sponge end remained in the back of the patient's mouth. Rn required assistance to hold patient's head still, use a light and extract the sponge end with tweezers from the back of the patient's mouth. Patient is intubated and ventilated. Swab was removed with no damage/harm to the patient. The swab from this event was discarded, but the 3 remaining dentip oral swabs were retained as well as the outer packaging for the oral pack. One oral swab was opened for investigation by clinical engineering. The adhesive between the plastic stick and sponge did not appear to have any gaps initially. With a small amount of rotating and pulling force for approx. 30 seconds, the sponge became detached from the plastic handle. Images of the handle can be viewed under attachments. It appears that adhesive is only present on one side of the plastic handle. Per site reporter: manufacturer representative was emailed, awaiting response. We have the remaining dentip swabs from the same pack, but not the broken swab from this event. Swabs and outer packaging will be given directly to medline rep.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7112368 |
| MDR Report Key | 7112368 |
| Date Received | 2017-12-13 |
| Date of Report | 2017-11-14 |
| Date of Event | 2017-11-06 |
| Report Date | 2017-11-14 |
| Date Reported to FDA | 2017-11-14 |
| Date Reported to Mfgr | 2017-11-14 |
| Date Added to Maude | 2017-12-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 3 |
| Brand Name | EXTENDED CARE SUCTION SWAB KIT WITH BIOTENE (DENTIP ORAL SWAB) |
| Generic Name | ORAL CARE, SUCTION SWAB KIT |
| Product Code | EHZ |
| Date Received | 2017-12-13 |
| Catalog Number | MDS096550 |
| Lot Number | 17-228 |
| ID Number | F5 13017 |
| Device Expiration Date | 2019-03-01 |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 0 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-13 |