MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2002-04-22 for 72-7000 CORD CLAMP CUTTER manufactured by Deroyal Industries, Inc..
[272286]
Cord clamp cutter broke when they were trying to cut the clamp. It broke at the top plastic piece and exposed the blade. The nurse stated that this could have pulled and cut the umbilical cord causing the pt to bleed. This occurred 2 times at this facility (a separate complaint will be filed).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1046367-2002-00058 |
| MDR Report Key | 390705 |
| Report Source | 05,07 |
| Date Received | 2002-04-22 |
| Date of Report | 2002-03-21 |
| Date of Event | 2002-01-01 |
| Date Facility Aware | 2002-01-01 |
| Report Date | 2002-03-21 |
| Date Reported to FDA | 2002-04-19 |
| Date Reported to Mfgr | 2002-03-21 |
| Date Mfgr Received | 2002-03-21 |
| Date Added to Maude | 2002-05-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8659387828 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 72-7000 CORD CLAMP CUTTER |
| Generic Name | UMBILICAL CORD CLAMP CUTTER |
| Product Code | JOK |
| Date Received | 2002-04-22 |
| Model Number | NA |
| Catalog Number | 72-7000 |
| Lot Number | NOT AVAILABLE |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 379748 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US |
| Baseline Brand Name | UMBILICAL CLAMP CUTTER |
| Baseline Generic Name | CORD CLAMP CUTTER |
| Baseline Model No | NA |
| Baseline Catalog No | 72-7000 |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-04-22 |