MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-26 for PALL PHARMASSURE? SYRINGE FILTER HP1002 manufactured by Pall International S?rl.
[185051218]
Filter was on iv tubing running amiodarone. Nurse states the filter was cracked. It appears to be an ongoing problem. Manufacturer response for pall pharmassure syringe filter, pall pharmassure 25 mm syringe filter (per site reporter). Nothing yet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9882456 |
| MDR Report Key | 9882456 |
| Date Received | 2020-03-26 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-16 |
| Report Date | 2020-02-25 |
| Date Reported to FDA | 2020-02-25 |
| Date Reported to Mfgr | 2020-03-26 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | PALL PHARMASSURE? SYRINGE FILTER |
| Generic Name | SYRINGE, PISTON |
| Product Code | FMF |
| Date Received | 2020-03-26 |
| Model Number | HP1002 |
| Catalog Number | HP1002 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PALL INTERNATIONAL S?RL |
| Manufacturer Address | 25 HARBOR PARK DR PORT WASHINGTON NY 11050 US 11050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |