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 2018-02-21 for PFHA STERILE LUER LOCK TIPCAP H93865001 manufactured by Baxter Healthcare - Englewood.
[100594375]
(b)(6). Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[100594376]
It was reported that the packaging of a luer lock tip cap was not correctly sealed. This was noted before use. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[104081382]
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The device was not returned; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2018-00929 |
| MDR Report Key | 7286266 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-02-21 |
| Date of Report | 2018-03-16 |
| Date of Event | 2018-02-01 |
| Date Mfgr Received | 2018-03-13 |
| Date Added to Maude | 2018-02-21 |
| 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 | PFHA STERILE LUER LOCK TIPCAP |
| Generic Name | DISPENSER, LIQUID MEDICATION |
| Product Code | KYX |
| Date Received | 2018-02-21 |
| Model Number | NA |
| Catalog Number | H93865001 |
| Lot Number | 1217961 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - ENGLEWOOD |
| Manufacturer Address | ENGLEWOOD CO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-21 |