MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2018-04-03 for CYSTOSCOPY IRRIGATION SET 2C4040 manufactured by Baxter Healthcare - Cartago.
[104443520]
Contact office: (b)(4). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[104443521]
It was reported that a hair was discovered within the packaging of a cysto/bladder irrigation set. This event was discovered during an unspecified process step before patient use. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[117736001]
The device was received for evaluation. A batch review was conducted and there were no deviations found related to the reported condition during the manufacture of this lot. Visual inspection was performed on the returned unit via the naked eye. The reported condition was verified due to a loose particle found inside the product pouch. The particle was concluded to be a hair. The possible cause was incorrect manufacturing practices during the manual assembly process. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2018-01836 |
| MDR Report Key | 7394190 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2018-04-03 |
| Date of Report | 2018-05-08 |
| Date of Event | 2018-03-08 |
| Date Mfgr Received | 2018-04-30 |
| Date Added to Maude | 2018-04-03 |
| 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 | CYSTOSCOPY IRRIGATION SET |
| Generic Name | SYSTEM, IRRIGATION, UROLOGICAL |
| Product Code | LJH |
| Date Received | 2018-04-03 |
| Returned To Mfg | 2018-04-09 |
| Model Number | NA |
| Catalog Number | 2C4040 |
| Lot Number | NI |
| 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 | 2018-04-03 |