MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-11 for MEDLINE HEMOSTAT DYNJ49371 manufactured by Medline Industries Inc..
[36050584]
A physician was stuck through double gloves by the ultra-sharpened tip of a contaminated hemostats during an invasive procedure. The physician sustained a puncture wound to his finger. Inspection of the hemostats after the incident revealed that the jaws were shaped asymmetrically with one side being sharpened to a pinpoint. Incident occurred during a hemodialysis catheter replacement procedure. The hemostats were from a custom basic interventional radiology kit. The markings "ii38" and "(b)(4)" are stamped into the device. Lot number of the actual procedure kit is unk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5059335 |
| MDR Report Key | 5367743 |
| Date Received | 2016-01-11 |
| Date of Report | 2016-01-11 |
| Date of Event | 2015-12-28 |
| Date Added to Maude | 2016-01-14 |
| 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 |
| 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 HEMOSTAT |
| Generic Name | HEMOSTATS |
| Product Code | HRQ |
| Date Received | 2016-01-11 |
| Catalog Number | DYNJ49371 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| 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 | 2016-01-11 |