MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05,06 report with the FDA on 2006-05-19 for DAR 15M/15F 25/CA 332U5663 manufactured by *.
[7839538]
No device was returned to the manufacture. Investigation of the device history records and complaint records for this product number from 1998 to date revealed there were no nonconformities during production or similar complaints.
Patient Sequence No: 1, Text Type: N, H10
[15554437]
A dar 15m catheter mount flexible adapter would not not fit an unspecified connection during patient use. It was reported the patient was a child.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2006-00568 |
| MDR Report Key | 718637 |
| Report Source | 04,05,06 |
| Date Received | 2006-05-19 |
| Date of Report | 2006-05-05 |
| Date Mfgr Received | 2006-05-05 |
| Date Added to Maude | 2006-05-26 |
| 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 | AMBER SIMINPOUR, ANALYST |
| Manufacturer Street | 4280 HACIENDA DR |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 9254634476 |
| Manufacturer G1 | * |
| Manufacturer Street | JUAREZ HENEQUEN, AVENDIA HENEQ 1181 PARQUE INDUSTRL SALVARCAR |
| Manufacturer City | CD. JUAREZ, CHIHUAHUA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAR |
| Generic Name | CATHETER MOUNT FLEXIBLE ADAPTER |
| Product Code | BZQ |
| Date Received | 2006-05-19 |
| Model Number | 15M/15F 25/CA |
| Catalog Number | 332U5663 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 707705 |
| Manufacturer | * |
| Manufacturer Address | AVENIDA HENEQUEN JUAREZ HENEQUEN CD. JUAREZ, CHIHUAHUA MX |
| Baseline Brand Name | DAR |
| Baseline Generic Name | CATHETER MOUNT FLEXIBLE ADAPTER |
| Baseline Model No | 15M/15F 25/CA |
| Baseline Catalog No | 332U5663 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-05-19 |