MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-10-30 for 3M? CUROS JET? DISINFECTING CAP FOR NEEDLELESS CONNECTORS N/A CFJ5-250 manufactured by 3m Health Care.
[126552248]
Product lot number was unknown. Without a lot number, expiration date, manufacture date and udi cannot be determined. (b)(4). Current product labeling notes the potential for intermittent leaking with baxter? Continu-flo? Solution set with clearlink? Luer activated valve. Please see the exact wording below: caution: there is a potential for intermittent leaking when baxter? Continu-flo? Solution set with clearlink? Luer activated valve or bd maxzero? Needle-free connectors are used under pressure with 3m? Curos jet? Disinfecting caps (cfj1-270 and cfj5-250. ) monitor these connectors if used under pressure. Alternatively, 3m? Curos? Disinfecting cap for needleless connectors (cff1-270 and cff10- 250) may be used. The 3m account representative reported this customer planned to start using 3m? Curos? Disinfecting cap for needleless connectors (cff1-270 and cff10- 250). End of report.
Patient Sequence No: 1, Text Type: N, H10
[126552249]
A nurse reported curos jet? Disinfecting caps were placed on the needleless connector y-sites of an icu patient's iv tubing. The patient allegedly experienced leaking of an unspecified cardiac medication. The leak was discovered and no patient harm occurred. No additional information was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2018-00099 |
| MDR Report Key | 8021845 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-30 |
| Date of Report | 2018-10-30 |
| Date of Event | 2018-10-16 |
| Date Mfgr Received | 2018-10-16 |
| Date Added to Maude | 2018-10-30 |
| 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 Contact | DIANNE GIBBS |
| Manufacturer Street | BUILDING 275 5W 06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517379117 |
| Manufacturer G1 | 3M COMPANY 3M COLUMBIA |
| Manufacturer Street | 5400 PARIS ROAD |
| Manufacturer City | COLUMBIA MO 65202 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 65202 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M? CUROS JET? DISINFECTING CAP FOR NEEDLELESS CONNECTORS |
| Generic Name | CUROS JET DISINFECTING CAP |
| Product Code | LKB |
| Date Received | 2018-10-30 |
| Model Number | N/A |
| Catalog Number | CFJ5-250 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-30 |