MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2010-10-08 for ACID CONC.7149 CF 3500ML CAPTI/F/D/NL CE 3C007149GR manufactured by Bieffe Medital S.p.a. - Grosotto Italy.
[1467962]
Baxter (b)(4) received a report that the product leaked in the overpouch before use. There was no patient injury or reaction reported. The sample is available for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[8711002]
(b)(4). The sample has been reported to be available for evaluation. Should additional information become available, a follow-up report will be submitted. A 510(k) number will not be provided in the emdr as this product is manufactured for distribution outside of the u. S. And does not have a 510(k) number. However, it is being reported because it is the same as or similar to product distributed within the u. S.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2010-04207 |
| MDR Report Key | 1862253 |
| Report Source | 01,05 |
| Date Received | 2010-10-08 |
| Date of Report | 2010-09-14 |
| Date of Event | 2010-09-01 |
| Date Mfgr Received | 2010-09-14 |
| Date Added to Maude | 2011-09-15 |
| 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 | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KAREN KIRBY |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472704541 |
| Manufacturer G1 | BIEFFE MEDITAL S.P.A. - GROSOTTO ITALY |
| Manufacturer Street | VIA NUOVA PROVINCIALE, GROSOTT |
| Manufacturer City | GROSOTTO |
| Manufacturer Country | IT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACID CONC.7149 CF 3500ML CAPTI/F/D/NL CE |
| Generic Name | SYSTEM, DIALYSATE DELIVERY, CENTRAL MULTIPLE PATIENT |
| Product Code | FKQ |
| Date Received | 2010-10-08 |
| Catalog Number | 3C007149GR |
| Lot Number | 09C2327 |
| Operator | PHARMACIST |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIEFFE MEDITAL S.P.A. - GROSOTTO ITALY |
| Manufacturer Address | VIA NUOVA PROVINCIALE, GROSOTT GROSOTTO IT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-08 |