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..
[591007]
Customer called to report false susceptible with e. Coli atcc #35218. The zone size should be 6mm and the customer is getting 23mm. Customer is following proper set up procedure and storage.
Patient Sequence No: 1, Text Type: D, B5
[7819018]
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 | 1119779-2007-00002 |
| MDR Report Key | 824841 |
| Report Source | 05 |
| Date Received | 2007-02-23 |
| Date of Report | 2007-02-19 |
| Date of Event | 2006-11-15 |
| Date Mfgr Received | 2006-11-15 |
| 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 | 1119779-02/19/07-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 |
| Returned To Mfg | 2006-11-22 |
| Model Number | * |
| Catalog Number | 231619 |
| Lot Number | 6167435 |
| ID Number | * |
| Device Expiration Date | 2008-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 812240 |
| 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 |