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 2018-05-18 for CAP, LG BORE, INT THD, STER H938711008 manufactured by Baxter Healthcare - Englewood.
[108666998]
Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[108666999]
It was reported that a black stain was observed on the primary packaging of an exactamix large bore cap. The contamination was discovered before patient use. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[120746840]
The actual device and forty-nine (49) companion samples were returned and an evaluation is complete. A visual inspection with magnification was performed and noted an embedded piece of dark foreign matter on the device packaging of the actual sample. The foreign matter did not come into contact with the device itself. No issues were observed on the 49 companion samples. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The reported problem was verified. The cause of the condition could not be determined. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2018-02954 |
| MDR Report Key | 7525363 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-05-18 |
| Date of Report | 2018-06-22 |
| Date of Event | 2018-04-23 |
| Date Mfgr Received | 2018-06-18 |
| Date Added to Maude | 2018-05-18 |
| 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 | 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 - ENGLEWOOD |
| Manufacturer Street | 14445 GRASSLANDS DR |
| Manufacturer City | ENGLEWOOD CO 80112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAP, LG BORE, INT THD, STER |
| Generic Name | DISPENSER, LIQUID MEDICATION |
| Product Code | KYX |
| Date Received | 2018-05-18 |
| Returned To Mfg | 2018-06-06 |
| Model Number | NA |
| Catalog Number | H938711008 |
| Lot Number | 1200230 |
| Device Expiration Date | 2019-11-30 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - ENGLEWOOD |
| Manufacturer Address | ENGLEWOOD CO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-18 |