MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-03 for PLEURAL CHEST TUBE manufactured by Pediavascular Inc..
[69047113]
Patient Sequence No: 1, Text Type: N, H10
[69047114]
Upon assessment of left pleural chest tube, noted site was leaking. After further assessment, no drainage noted in tubing. Chest tube noted to be cracked in multiple places (chest tube is very small rigid tubing) and leaking serous fluid from cracks. New dressing placed on site and chest tube secured with tape to prevent further cracking or leaking. After repositioning patient with diaper change, chest tube became completely broken and disconnected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6376717 |
| MDR Report Key | 6376717 |
| Date Received | 2017-03-03 |
| Date of Report | 2017-02-21 |
| Date of Event | 2017-02-16 |
| Report Date | 2017-02-21 |
| Date Reported to FDA | 2017-02-21 |
| Date Reported to Mfgr | 2017-02-21 |
| Date Added to Maude | 2017-03-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | PLEURAL CHEST TUBE |
| Product Code | OFA |
| Date Received | 2017-03-03 |
| ID Number | 3 FRENCH PIGTAIL CATHETER |
| Operator | NURSE |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PEDIAVASCULAR INC. |
| Manufacturer Address | 7181 CHAGRIN RD. STE. 250 CHAGRIN FALLS OH 44023 US 44023 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-03 |