MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-02-12 for HEMOSTAT OB6163C 166 manufactured by Sterile Concept.
[50524]
Cord clamped with hemostat as per routine. When infant placed on warmer bed and was being dried hemostat slid off cord and infant was bleeding from cord. Dr clamped cord with hand until a cord clamp was replaced on cord. Approx 5 cc of blood loss. Staff reported clamp defective and failed to hold. It would not close completely. While cleaning clamp, post event, one prong broke off hemostat. Hemostat from ob pack, vaginal delivery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 81276 |
| MDR Report Key | 81276 |
| Date Received | 1997-02-12 |
| Date of Report | 1996-11-19 |
| Date of Event | 1996-11-06 |
| Date Facility Aware | 1996-11-19 |
| Report Date | 1996-11-19 |
| Date Reported to Mfgr | 1996-11-19 |
| Date Added to Maude | 1997-04-08 |
| 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 | HEMOSTAT |
| Generic Name | HEMOSTAT |
| Product Code | HRQ |
| Date Received | 1997-02-12 |
| Model Number | OB6163C |
| Catalog Number | 166 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 80714 |
| Manufacturer | STERILE CONCEPT |
| Manufacturer Address | 5100 COMMERCE RD RICHARD VA 232342271 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-02-12 |