MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-06-06 for CYSTOSCOPY IRRIGATION SET JC4040 manufactured by Baxter Healthcare - Cartago.
[110368131]
(b)(4). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[110368132]
It was reported that there was particulate matter in a cysto/bladder irrigation set. The reporter stated that after the packaging was opened and the medication spiked, a small piece of red plastic was noted in the chamber. Upon further inspection, the customer noticed that the red cap over the spike was split and a small piece was missing. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[114187903]
The device was received for evaluation. A visual inspection was performed and a small piece of red plastic was observed inside the chamber or housing. A spectrophotometric comparison was performed on the particulate matter and it was determined to of the same material as a component. The reported condition was verified. The cause of the reported condition was an assembly issue. 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
[114187904]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2018-03436 |
| MDR Report Key | 7573241 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-06 |
| Date of Report | 2018-07-13 |
| Date Mfgr Received | 2018-07-12 |
| Device Manufacturer Date | 2017-09-08 |
| Date Added to Maude | 2018-06-06 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2018-06-06 |
| Returned To Mfg | 2018-07-10 |
| Model Number | NA |
| Catalog Number | JC4040 |
| Lot Number | R17I07023 |
| 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 | 2018-06-06 |