MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-14 for PALL FILTER POSIDYNE ELD ELD96LL manufactured by Pall Corporation.
[145296333]
The iv filter was prepped in the beginning of the procedure in order to prevent bubbles from an iv entering the pt. The filter was prepped in the standard fashion, with no bubbles remaining after the prep. However, a few mins later, when it was soon to be connected to the access sheath, there was a large bubble in the filter. Filter was then removed and a new filter was prepped.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086662 |
| MDR Report Key | 8612903 |
| Date Received | 2019-05-14 |
| Date of Report | 2019-05-10 |
| Date of Event | 2019-05-03 |
| Date Added to Maude | 2019-05-15 |
| 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 |
| 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 | PALL FILTER |
| Generic Name | FILTER, INFUSION LINE |
| Product Code | FPB |
| Date Received | 2019-05-14 |
| Returned To Mfg | 2019-05-03 |
| Model Number | POSIDYNE ELD |
| Catalog Number | ELD96LL |
| Lot Number | 18-151 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PALL CORPORATION |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-05-14 |