MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2004-06-17 for PALL EBDS NA manufactured by Pall Medsep.
[389185]
During a product qualification at a user facility, prior to clinical implementation, unexpected results were obtained. Using purposely-contaminated samples as a positive control, the instrument initially correctly determined that the sample was contaminated, but on subsequent determinations, did not indicate such pouches to be contaminated. A second instrument was tested, and consistently gave the expected determination indication contamination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2013342-2004-00005 |
| MDR Report Key | 595557 |
| Report Source | 05,06,07 |
| Date Received | 2004-06-17 |
| Date of Report | 2004-04-27 |
| Date of Event | 2004-04-22 |
| Date Facility Aware | 2004-04-22 |
| Date Reported to Mfgr | 2004-04-27 |
| Date Mfgr Received | 2004-04-27 |
| Date Added to Maude | 2005-04-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Manufacturer Contact | LEONARD BERMAN, PH.D |
| Manufacturer Street | 2200 NORTHERN BLVD |
| Manufacturer City | EAST HILLS NY 11548 |
| Manufacturer Country | US |
| Manufacturer Postal | 11548 |
| Manufacturer Phone | 5164845400 |
| Manufacturer G1 | PALL MEDSEP |
| Manufacturer Street | 1630 INDUSTRIAL PARK ST. |
| Manufacturer City | COVINA CA 91722 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91722 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALL EBDS |
| Generic Name | BACTERIA DETECTION SYSTEM SAMPLE SET |
| Product Code | MZC |
| Date Received | 2004-06-17 |
| Model Number | EBDS |
| Catalog Number | NA |
| Lot Number | SET L/N 0400568 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 585383 |
| Manufacturer | PALL MEDSEP |
| Manufacturer Address | * COVINA CA * US |
| Baseline Brand Name | PALL EBDS |
| Baseline Generic Name | BACTERIA DETECTION SYSTEM SAMPLE SET |
| Baseline Model No | EBDS |
| Baseline Catalog No | NA |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-06-17 |