MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-27 for CATHETER, 28 FR RIGHT ANGLE 8128 manufactured by Atrium Medical.
[118746388]
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
[118746389]
Report received stated that a nurse was obtaining products from central supply stock for a case and found thoracic chest tube catheters that the packaging was unsealed on one end.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3011175548-2018-00922 |
MDR Report Key | 7818245 |
Date Received | 2018-08-27 |
Date of Report | 2018-08-27 |
Date of Event | 2018-08-13 |
Date Mfgr Received | 2018-09-05 |
Device Manufacturer Date | 2018-03-05 |
Date Added to Maude | 2018-08-27 |
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 |
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 | 2018-08-27 |
Returned To Mfg | 2018-08-21 |
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 | 2018-08-27 |