MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-06-29 for CNB600 331694 manufactured by B. Braun Medical, Inc..
[223366]
The user facility reports the following: 6" of catheter missing upon removal of catheter. Right side brachial plexus/infraclavicular. Unable to see catheter on x-ray.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-2001-00018 |
| MDR Report Key | 340271 |
| Report Source | 05 |
| Date Received | 2001-06-29 |
| Date of Report | 2001-06-19 |
| Date of Event | 2001-05-25 |
| Date Facility Aware | 2001-05-29 |
| Report Date | 2001-06-18 |
| Date Mfgr Received | 2001-05-29 |
| Date Added to Maude | 2001-07-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANDREW HARAKAL |
| Manufacturer Street | 901 MARCON BLVD |
| Manufacturer City | ALLENTOWN PA 18103 |
| Manufacturer Country | US |
| Manufacturer Postal | 18103 |
| Manufacturer Phone | 6102660500 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NA |
| Generic Name | CNB600 6-IN INSULATED TUOHY |
| Product Code | BXN |
| Date Received | 2001-06-29 |
| Model Number | CNB600 |
| Catalog Number | 331694 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 329592 |
| Manufacturer | B. BRAUN MEDICAL, INC. |
| Manufacturer Address | 901 MARCON BLVD. ALLENTOWN PA 18103 US |
| Baseline Brand Name | NA |
| Baseline Model No | CNB600 |
| Baseline Catalog No | 331694 |
| Baseline ID | NA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K860126 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-06-29 |