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 2004-03-23 for PALL BDS SAMPLE SET BDS 02 NA manufactured by Pall Biomedical Products Co..
[338139]
It was reported that during use in a non-clinical setting, one(1) of two(2) devices undergoing process validation testing at a user facility gave unexpected readings which led to an erroneous conclusion about the sample being tested (false negative for bacterial contamination), during qc evaluation of bb processes. When the two(2) instruments that were used for validation testing again the next day, after replacement of the disposable sampling tube assemblies, both instruments gave comparable expected readings.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432733-2004-00001 |
| MDR Report Key | 537673 |
| Report Source | 05,06,07 |
| Date Received | 2004-03-23 |
| Date of Report | 2004-02-24 |
| Date of Event | 2004-02-20 |
| Date Facility Aware | 2004-02-20 |
| Date Reported to Mfgr | 2004-02-24 |
| Date Mfgr Received | 2004-02-24 |
| Date Added to Maude | 2004-08-06 |
| 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 | 3 |
| Manufacturer Contact | LEONARD BERMAN, PH.D |
| Manufacturer Street | 2200 NORTHERN BOULEVARD |
| Manufacturer City | EAST HILLS NY 11548 |
| Manufacturer Country | US |
| Manufacturer Postal | 11548 |
| Manufacturer Phone | * |
| Manufacturer G1 | PALL BIOMEDICAL PRODUCTS COMPANY |
| Manufacturer Street | 2200 NORTHERN BOULEVARD |
| Manufacturer City | EAST HILLS NY 11548 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11548 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALL BDS SAMPLE SET |
| Generic Name | BACTERIA DETECTION SYSTEM |
| Product Code | MZC |
| Date Received | 2004-03-23 |
| Model Number | BDS 02 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 526924 |
| Manufacturer | PALL BIOMEDICAL PRODUCTS CO. |
| Manufacturer Address | 2200 NORTHERN BLVD. EAST HILLS NY 11548 US |
| Baseline Brand Name | PALL BDS SAMPLE SET |
| Baseline Generic Name | BACTERIA DETECTION SYSTEM |
| Baseline Model No | BDS 02 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | BACTERIA DETECTION SYSTEM |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K020014 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-03-23 |