MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-17 for FORMALIN 10% BUFFERED PREFILLED * C4320-15B manufactured by Baxter Healthcare Corp. Iv Div..
[49606]
Upon opening a case of the s/p prefilled buffered 10% formalin, 100 jars per cse, one jar had some foreign material floating in it. The remaining cases were inspected and 18 jars were found from lot number 15129 and 5 jars from lot number 15130 were found containing foreign material. The jars were suspended from use and are available for testing if needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4001808 |
| MDR Report Key | 76566 |
| Date Received | 1997-03-17 |
| Date of Report | 1996-08-08 |
| Date Added to Maude | 1997-03-19 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORMALIN 10% BUFFERED PREFILLED |
| Generic Name | FORMALIN 10% BUFFERED PREFILLED |
| Product Code | IFP |
| Date Received | 1997-03-17 |
| Model Number | * |
| Catalog Number | C4320-15B |
| Lot Number | 15129/15130 |
| ID Number | TD70019,M96232047,08-08-123238 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 76289 |
| Manufacturer | BAXTER HEALTHCARE CORP. IV DIV. |
| Manufacturer Address | PO BOX 490 RT 120 & WILSON RD ROUND LAKE IL 60073 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1997-03-17 |