MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-28 for MEDICHOICE * manufactured by Owen's & Minor.
[5103236]
One side of the metal hemostat broke off when the nurse clamped it down on tubing while disconnecting tubing from the patient's nasogastric tube. The nurse reported that she did not use extra force using the device. ======================manufacturer response for metal hemostat, medichoice (per site reporter). ======================it was returned to the vendor representative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4173760 |
| MDR Report Key | 4173760 |
| Date Received | 2014-09-28 |
| Date of Report | 2014-09-28 |
| Date of Event | 2014-01-22 |
| Report Date | 2014-09-28 |
| Date Reported to FDA | 2014-09-28 |
| Date Reported to Mfgr | 2014-10-15 |
| Date Added to Maude | 2014-10-15 |
| 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 | 3 |
| 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 | MEDICHOICE |
| Generic Name | HEMOSTAT |
| Product Code | HRQ |
| Date Received | 2014-09-28 |
| Returned To Mfg | 2014-02-06 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OWEN'S & MINOR |
| Manufacturer Address | 9120 LOCKWOOD BLVD MECHANICSVILLE, VA 23116 US 23116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-28 |