MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-21 for MILLEX GV FILTER UNIT 0.22 SLGU033RS manufactured by Merck Millipore.
[109069996]
Attached the millex g. V. 0. 22 filter when priming the tubing. Nurse went to attach the filter to patient and started the infusion. Noted immediately that the filter was leaking, from filter itself while attached to the patient. Removed the filter and replaced with a new one. No leaking noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077369 |
| MDR Report Key | 7533940 |
| Date Received | 2018-05-21 |
| Date of Report | 2018-05-17 |
| Date of Event | 2018-04-26 |
| Date Added to Maude | 2018-05-22 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | MILLEX GV FILTER UNIT 0.22 |
| Generic Name | FILTER, CONDUCTION, ANESTHETIC |
| Product Code | BSN |
| Date Received | 2018-05-21 |
| Catalog Number | SLGU033RS |
| Lot Number | R7MA59116 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MERCK MILLIPORE |
| Manufacturer Address | BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-21 |