MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-14 for MEDITECH 20-550 manufactured by Meditech.
[20204161]
Procedure: ct guided intra-abdominal catheter placementproblem: 2 cm distal end of catheter broke off in patient's abdominal fascia during repositioning. Catheter was very brittle and broke off at side hole. No abnormal procedure was done; catheter should not have broken.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 15112 |
| MDR Report Key | 15112 |
| Date Received | 1994-01-14 |
| Date of Report | 1993-07-16 |
| Date of Event | 1993-07-12 |
| Date Facility Aware | 1993-07-12 |
| Report Date | 1993-07-16 |
| Date Reported to Mfgr | 1993-07-16 |
| Date Added to Maude | 1994-08-09 |
| 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 | MEDITECH |
| Generic Name | SINGLE STEP CATHETER |
| Product Code | FKO |
| Date Received | 1994-01-14 |
| Returned To Mfg | 1993-07-16 |
| Model Number | 20-550 |
| Lot Number | 52200 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 15106 |
| Manufacturer | MEDITECH |
| Manufacturer Address | 650 PLEASANT STREET WATERTOWN MA 02172 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-01-14 |