MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-09-27 for CATHETER, 28 FR RIGHT ANGLE 8128 manufactured by Atrium Medical.
[122169962]
We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.
Patient Sequence No: 1, Text Type: N, H10
[122169963]
Report received stated that the manufacturing seal for the thoracic chest tube catheter pouch was found to be unsealed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011175548-2018-01047 |
| MDR Report Key | 7915801 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-09-27 |
| Date of Report | 2018-09-27 |
| Date of Event | 2018-09-13 |
| Date Mfgr Received | 2018-10-05 |
| Device Manufacturer Date | 2018-03-05 |
| Date Added to Maude | 2018-09-27 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 40 CONTINENTAL BLVD |
| Manufacturer City | MERRIMACK NH 03054 |
| Manufacturer Country | US |
| Manufacturer Postal | 03054 |
| Manufacturer G1 | ATRIUM MEDICAL |
| Manufacturer Street | 40 CONTINENTAL BLVD |
| Manufacturer City | MERRIMACK NH 03054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CATHETER, 28 FR RIGHT ANGLE |
| Generic Name | CATHETER, CHOLANGIOGRAPHY |
| Product Code | GBZ |
| Date Received | 2018-09-27 |
| Returned To Mfg | 2018-10-04 |
| Model Number | 8128 |
| Catalog Number | 8128 |
| Lot Number | ME221275 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ATRIUM MEDICAL |
| Manufacturer Address | 40 CONTINENTAL BLVD MERRIMACK NH 03054 US 03054 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-27 |