MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-02-23 for BBL SENSI-DISC TICARCILLIN TIC-75 * 231619 manufactured by Bd Caribe, Ltd..
[15698895]
Customer was having problems with the discs. Customer has been performing qc with e. Coli 25922 and p. Aeruginosa and had acceptable results. Customer started noticing some patient isolates, mainly k. Pneumo. , that were sensitive to ticarcillin, when customer knew they should be resistant. Customer tested isolates on vitek, and vitek called them resistant. Customer then set up e. Coli 35218, and got a zone size of 20, when it should be 6.
Patient Sequence No: 1, Text Type: D, B5
[15918296]
Internal investigation of retention product also exhibit a false susceptible result when tested against e. Coli atcc 35218. Internal investigation has shown that this lot of ticarcillin contains clavulanic acid, a compound that inactivates e. Coli atcc 35218's beta-lactamase enzymes, allowing the antibiotic to kill the organism creating a zone of growth inhibition with the kirby-bauer test methodology.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2007-00003 |
| MDR Report Key | 824835 |
| Report Source | 05 |
| Date Received | 2007-02-23 |
| Date of Report | 2007-02-19 |
| Date of Event | 2007-01-30 |
| Date Mfgr Received | 2007-01-30 |
| Device Manufacturer Date | 2006-06-01 |
| Date Added to Maude | 2007-03-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JOHN GERLICH |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164464 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | 1119779-02/19/2007-R001 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BBL SENSI-DISC TICARCILLIN TIC-75 |
| Generic Name | ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
| Product Code | JTN |
| Date Received | 2007-02-23 |
| Model Number | * |
| Catalog Number | 231619 |
| Lot Number | 6167435 |
| ID Number | * |
| Device Expiration Date | 2008-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 812234 |
| Manufacturer | BD CARIBE, LTD. |
| Manufacturer Address | * CAYEY PR * US |
| Baseline Brand Name | BBL SENSI-DISC TICARCILLIN TIC-75 |
| Baseline Generic Name | ANTIMICROBIAL SUSCEPTIBILITY TEST DISC |
| Baseline Model No | * |
| Baseline Catalog No | 231619 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2007-02-23 |