MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-10-29 for UMBILICAL CORD CLAMP REMOVER * 11009 manufactured by Medichoice.
[2342279]
While cutting the umbilical cord clamp on this baby, the cord clamp remover broke. The blade came out of the tool and staff could not remove the tool or get the blade out of the tool to take the clamp off the infant's umbilical cord. Staff had to break the cord clamp, being careful not to slice the skin of the patient or their own skin with the razor sharp blade. It took over 30 minutes for staff to remove the tool, clamp, and blade from the area.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2326986 |
| MDR Report Key | 2326986 |
| Date Received | 2011-10-29 |
| Date of Report | 2011-10-26 |
| Date of Event | 2011-04-24 |
| Report Date | 2011-10-26 |
| Date Reported to FDA | 2011-10-29 |
| Date Added to Maude | 2011-11-07 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | UMBILICAL CORD CLAMP REMOVER |
| Generic Name | CORD CLAMP, REMOVER |
| Product Code | HFW |
| Date Received | 2011-10-29 |
| Returned To Mfg | 2011-05-24 |
| Model Number | * |
| Catalog Number | 11009 |
| Lot Number | CCH12-52 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | 0 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICHOICE |
| Manufacturer Address | 9120 LOCKWOOD BOULEVARD MECHANICSVILLE VA 23116 US 23116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-10-29 |