MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-07-17 for KELLY CLAMP * manufactured by Integra Lifesciences Corporation.
[19997676]
Kelly clamp was handed to doctor by certified surgical technologist (cst) at delivery to clamp the umbilical cord to obtain a segment of cord blood. The head of the clamp broke away from the body of the clamp when she attempted to lock the handle. The instrument and broken clamp head was removed off field, handed to rn circulator, and double bagged in biohazard bag with patient's label. Rn handed the bagged instrument to charge rn. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3273393 |
| MDR Report Key | 3273393 |
| Date Received | 2013-07-17 |
| Date of Report | 2013-07-17 |
| Date of Event | 2013-06-30 |
| Report Date | 2013-07-17 |
| Date Reported to FDA | 2013-07-17 |
| Date Reported to Mfgr | 2013-08-09 |
| Date Added to Maude | 2013-08-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KELLY CLAMP |
| Generic Name | CLAMP, VASCULAR, REPROCESSED |
| Product Code | NMF |
| Date Received | 2013-07-17 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-17 |