MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-18 for CELL WASH/INFUSION BAG 791-03 manufactured by Pall Medical.
[45761665]
Second incident in 1 week regarding: pall medical cell wash/infusion bag set, code 791-03, lot 1553062, expiration 2018-05. After centrifugation of cord blood cells, leaking of product was noticed from the seam of cell wash/infusion bag set. First incident on (b)(6) 2016, the second on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062404 |
| MDR Report Key | 5671052 |
| Date Received | 2016-05-18 |
| Date of Report | 2016-05-18 |
| Date of Event | 2016-05-18 |
| Date Added to Maude | 2016-05-23 |
| 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 | CELL WASH/INFUSION BAG |
| Generic Name | CELL WASH/INFUSION BAG |
| Product Code | KSR |
| Date Received | 2016-05-18 |
| Model Number | 791-03 |
| Lot Number | 1553062 |
| Device Expiration Date | 2018-05-01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PALL MEDICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-05-18 |