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 2020-03-25 for INFUSOR J2C1711 manufactured by Baxter Healthcare Corporation.
[184860442]
The device has been received and the evaluation is in progress. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[184860443]
It was reported that a small volume infusor leaked. This was identified at the patient? S home by the patient when they observed that the portable bag the infusor was in was wet. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5
[189078963]
The lot was manufactured from august 05, 2019 - august 06, 2019. The device was received containing approximately 110 ml of fluid in the bladder. During visual inspection the bag that contained the unit was observed dry. Functional testing was performed, the blue winged luer cap was hand tightened by manually rotating the cap until the cap could no longer be rotated. The unit was filled with water to a nominal volume and monitored for twenty-four hours. No signs of leak were observed at the blue winged luer cap. The reported condition was not verified. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. A nonconformance has been opened to address this issue. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2020-01700 |
| MDR Report Key | 9878236 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-25 |
| 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 - IRVINE |
| Manufacturer Street | 17511 ARMSTRONG AVENUE BUILDING 3 |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INFUSOR |
| Generic Name | PUMP, INFUSION, ELASTOMERIC |
| Product Code | MEB |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-03-11 |
| Model Number | NA |
| Catalog Number | J2C1711 |
| Lot Number | 19H004 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Manufacturer Address | DEERFIELD IL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |