MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2000-04-28 for 3 LUMEN, 7F, 30CM CATHETER W/HEPARIN 41413 manufactured by Abbott Laboratories.
[192588]
Report of central line catheters, cracking, splitting, or snapping rec'd. Rec'd report of 3 undocumented incidences of central line catheter cracking or splitting, and 1 documented incident, the customer reported that "during a code, the wire cracked "and the catheter snapped in half. " the nurse was at the bedside at the time of the event and placed a hemostat on the catheter immediately. The catheter was changed out to solve the problem. No pt harm was reported related to this event. At the time, the customer questioned whether the pt had experienced air embolus related to the event, but this has since been ruled out. The pt expired on 3/25/00. Add'l info was requested, but no further info was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713468-2000-00022 |
| MDR Report Key | 276067 |
| Report Source | 00 |
| Date Received | 2000-04-28 |
| Date of Report | 2000-03-27 |
| Date of Event | 2000-03-25 |
| Date Mfgr Received | 2000-03-27 |
| Device Manufacturer Date | 1999-09-01 |
| Date Added to Maude | 2000-05-04 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | FRANK POKROP, DIRECTOR |
| Manufacturer Street | DEPT 389, AP30 200 ABBOTT PARK RD |
| Manufacturer City | ABBOTT PARK IL 600646157 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646157 |
| Manufacturer Phone | 8479378473 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3 LUMEN, 7F, 30CM CATHETER W/HEPARIN |
| Generic Name | CATHETER |
| Product Code | GBP |
| Date Received | 2000-04-28 |
| Returned To Mfg | 2000-04-04 |
| Model Number | NA |
| Catalog Number | 41413 |
| Lot Number | 57-340-SN |
| ID Number | NA |
| Device Expiration Date | 2001-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 267205 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 4455 ATHERTON SALT LAKE CITY UT 84123 US |
| Baseline Brand Name | 3 LUMEN, 7F, 30CM CATHETER W/HEPARIN |
| Baseline Generic Name | CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | 41413 |
| Baseline ID | NA |
| Baseline Device Family | CATHETER, MULTIPLE LUMEN |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | 18 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K832595 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-04-28 |