MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-23 for BAXTER 2 LITER EMPTY BAGS manufactured by Baxter Healthcare Corporation.
[125281296]
Our institution discovered that the baxter 2 liter empty bags had a leak from the central port (the bag has 3 ports altogether) after 2 tpns were made prior to it being delivered to the patient. This is the port that nursing may spike prior to administration but pharmacy does not manipulate this port. Therefore, the port should not have leaked prior to the bag being delivered to the patient's area for administration. All of the lot #60126015 for the baxter 2 liter empty bags have been quarantined and the manufacturer will be notified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080762 |
| MDR Report Key | 7999446 |
| Date Received | 2018-10-23 |
| Date of Report | 2018-10-22 |
| Date of Event | 2018-10-20 |
| Date Added to Maude | 2018-10-24 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BAXTER 2 LITER EMPTY BAGS |
| Generic Name | EQUIPMENT LABORATORY, GENERAL PURPOSE, LABELLED OR PROMOTED FOR SPECIFIC MEDICAL |
| Product Code | LXG |
| Date Received | 2018-10-23 |
| Lot Number | 60126015 |
| Device Expiration Date | 2018-10-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-23 |