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 2018-01-22 for ADAPTER, LL TO CATHETER TIP ST H93813601 manufactured by Baxter Healthcare - Englewood.
[98080669]
This event occurred in (b)(6) 2017. (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[98080670]
It was reported that there was a particle in the packaging of a catheter tip adapter. This occurred for thirty-eight (38) separate packages. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[104094977]
Thirty-nine (39) actual samples were received for evaluation and an evaluation is complete. A visual inspection with magnification was performed and the reported condition was confirmed for three samples. One sample was found with foreign material inside of the sealed packaging. One sample had loose foreign material on the adapter surface which measured at 0. 10 square millimeters. The third sample was found with embedded particulate matter that measured at 0. 10 square millimeters on the adapter body. The reported condition was verified for these three samples. An assignable cause could not be determined. The reported issue was not verified for the other thirty-six samples. A batch review was conducted and there were no deviations found related to the 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 | 1416980-2018-00309 |
| MDR Report Key | 7210565 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-01-22 |
| Date of Report | 2018-03-16 |
| Date Mfgr Received | 2018-03-08 |
| Date Added to Maude | 2018-01-22 |
| 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 |
| 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 | ADAPTER, LL TO CATHETER TIP ST |
| Generic Name | DISPENSER, LIQUID MEDICATION |
| Product Code | KYX |
| Date Received | 2018-01-22 |
| Returned To Mfg | 2018-01-24 |
| Model Number | NA |
| Catalog Number | H93813601 |
| Lot Number | 60078440 |
| 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 | 2018-01-22 |