MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-02-20 for TUR IRRIGATION SET 2C4005 manufactured by Baxter Healthcare - Cartago.
[100526420]
(b)(4). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[100526421]
It was reported that the sterile packaging of three (3) y-type tur irrigation sets was open. This event was discovered before patient use during the kitting process. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[104097634]
Two devices were received for evaluation. During visual examination, the pouch was observed open; therefore, the peel and seal width test was performed to evaluate the quality of the seal. The results were satisfactory due to the sealed is uniformed across the sealed area. Also, it was observed that the packaging material is correctly aligned. The reported condition was verified; however, the cause of the condition could not be determined. There are controls in place to detect and prevent an opening packaging in the manufacturing. The third device was not returned for evaluation; therefore, a device analysis could not be completed. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2018-00912 |
| MDR Report Key | 7284494 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-02-20 |
| Date of Report | 2018-03-23 |
| Date Mfgr Received | 2018-03-12 |
| Device Manufacturer Date | 2017-07-19 |
| Date Added to Maude | 2018-02-20 |
| 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 | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | BAXTER HEALTHCARE - CARTAGO |
| Manufacturer Street | SEE H10 SEE H10 |
| Manufacturer City | CARTAGO 30106 |
| Manufacturer Country | CS |
| Manufacturer Postal Code | 30106 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TUR IRRIGATION SET |
| Generic Name | SYSTEM, IRRIGATION, UROLOGICAL |
| Product Code | LJH |
| Date Received | 2018-02-20 |
| Returned To Mfg | 2018-02-16 |
| Model Number | NA |
| Catalog Number | 2C4005 |
| Lot Number | R17G18057 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - CARTAGO |
| Manufacturer Address | CARTAGO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-20 |