MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-09-12 for MEDICHOICE UMBILICAL CORD CLAMP * 1773088101 manufactured by Owens & Minor, Inc..
[964913]
Nurse discovered bleeding from umbilical cord. This is the third incident in which the cord clamp has failed. In reviewing these incidents, we have hypothesized that the transponder for the infant security system may have contributed to the failure of the clamp. The transponder is placed in the ring at one end of the clamp. The transponder is held very tightly by clamps from this manufacturer. (nursing staff does not recall having similar problems with our previous clamp manufacturer. ) after reporting these incidents to the clamp manufacturer, we have been informed that their device is not compatible with the transponder system. Also, according to the maker's of the transponder system, the only clamp that is designed to be used with the system is their own proprietary clamp.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1180303 |
| MDR Report Key | 1180303 |
| Date Received | 2008-09-12 |
| Date of Report | 2008-09-12 |
| Date of Event | 2008-09-12 |
| Report Date | 2008-09-12 |
| Date Reported to FDA | 2008-09-12 |
| Date Added to Maude | 2008-10-01 |
| 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 | MEDICHOICE UMBILICAL CORD CLAMP |
| Generic Name | UMBILICAL CORD CLAMP |
| Product Code | HFW |
| Date Received | 2008-09-12 |
| Model Number | * |
| Catalog Number | 1773088101 |
| Lot Number | CSG10-01 |
| ID Number | * |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 1209618 |
| Manufacturer | OWENS & MINOR, INC. |
| Manufacturer Address | 9120 LOCKWOOD BOULEVARD MECHANICSVILLE VA 23116 US |
| Brand Name | MY CHILD INFANT PROTECTION SYSTEM |
| Generic Name | INFANT ABDUCTION SYSTEM |
| Product Code | FRP |
| Date Received | 2008-09-12 |
| Model Number | PRO-ROAM-UMB |
| Catalog Number | PRO-ROAM-UMB |
| Lot Number | * |
| ID Number | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 2 |
| Device Event Key | 1209619 |
| Manufacturer | PROSEC PROTECTION SYSTEMS INC. |
| Manufacturer Address | 1985 SWARTHMORE AVENUE, SUITE LAKEWOOD NJ 08701 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-09-12 |