MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2015-01-07 for ACCUSOL RPE9249 manufactured by Baxter Healthcare - Castlebar.
[5362504]
During evaluation of a returned accusol solution bag for clearflex was reported to have a tear on the apex of the long peel seal with the print side up. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[12687400]
Complaint no: (b)(4). The device was returned for evaluation. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. A visual inspection was performed and a tear approximately 4mm in length on the apex of the long peel seal, print side up was found. However, the cause was not determined. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2015-00682 |
| MDR Report Key | 4392388 |
| Report Source | 01,05,07 |
| Date Received | 2015-01-07 |
| Date of Report | 2014-12-08 |
| Date Mfgr Received | 2014-12-08 |
| Date Added to Maude | 2015-01-22 |
| 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 | KINGA ALMASAN |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | BAXTER HEALTHCARE - CASTLEBAR |
| Manufacturer Street | MONEEN ROAD |
| Manufacturer City | CASTELBAR |
| Manufacturer Country | EI |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACCUSOL |
| Generic Name | STIMULATOR, ELECTRICAL, NON-IMPLANTABLE, FOR INCONTINENCE |
| Product Code | KPI |
| Date Received | 2015-01-07 |
| Returned To Mfg | 2014-11-24 |
| Catalog Number | RPE9249 |
| Lot Number | 13I05G71 |
| Device Expiration Date | 2015-08-31 |
| Operator | PHARMACIST |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - CASTLEBAR |
| Manufacturer Address | MONEEN ROAD CASTELBAR EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-07 |