MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-04-21 for C6001, 5MMX33CM PROB/VALV DB, G2, 12/BX 101471293 manufactured by Applied Medical.
[43287187]
No product is being returned for evaluation and no lot # has been provided to manufacturer. A follow-up report will be sent once the results have been analyzed. In accordance to 21 cfr 803. 56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.
Patient Sequence No: 1, Text Type: N, H10
[43287188]
Procedure performed unknown. "no, specific lot number, just an overall remark compared to his habitual used system, of conmed: due to flexible tubing, at the level of the suction recipient, the tubing get bended and the system doesn't aspirate anymore. It might be due to light hot saline water they use to rinse, but not was always like that. So, tubing of conmed is more stable. Connection blue plastic should be wider, because it's hard to get it plugged on the recipient's connection point. Spikes are very difficult to get in the 1 liter saline bags. It should be a more tapered design, smaller at the tip of the spike and becoming 'wider' to, the end. " patient status- perfect.
Patient Sequence No: 1, Text Type: D, B5
[55019800]
The incident product was not returned for evaluation. In the absence of the subject device, it is difficult to determine the root cause of the incident. A review of the manufacturing records for this lot could not be performed as no lot number was provided.? Although the root cause of the incident could not be determined, applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary. In accordance to 21 cfr 803. 56, if we obtain additional information, which was not known or was not available when this report was submitted, then the supplemental report will be submitted to the fda.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027111-2016-00270 |
| MDR Report Key | 5595880 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-04-21 |
| Date of Report | 2016-03-23 |
| Date Mfgr Received | 2016-09-16 |
| Date Added to Maude | 2016-04-21 |
| 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 Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138233 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C6001, 5MMX33CM PROB/VALV DB, G2, 12/BX |
| Generic Name | FHF |
| Product Code | FHF |
| Date Received | 2016-04-21 |
| Model Number | C6001 |
| Catalog Number | 101471293 |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-21 |