MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-05-31 for 3M? CUROS JET? DISINFECTING CAP FOR NEEDLELESS CONNECTORS N/A CFJ1-270 manufactured by 3m Health Care.
[110051916]
No sample has been received to date. (b)(4) was received from the facility and the fda. 3m has recently implemented a labeling change informing users of the potential for intermittent leaking with baxter? Continu-flo? Solution set with clearlink? Luer activated valve in addition to bd maxzero? Needle-free connectors. 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. End of report
Patient Sequence No: 1, Text Type: N, H10
[110051917]
A customer reported the following information via a medwatch report: "administered medication to specified {sicu} patient and curos jet? Cap malfunction occurred. Medication was not properly administered to the patient, but found to leak onto the floor. Curos jet cap was kept and will be returned to company per management request. Medication then administered late to patient. No patient impact occurred. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2018-00059 |
| MDR Report Key | 7557706 |
| Report Source | USER FACILITY |
| Date Received | 2018-05-31 |
| Date of Report | 2018-05-31 |
| Date of Event | 2018-04-26 |
| Date Mfgr Received | 2018-05-09 |
| Device Manufacturer Date | 2018-01-03 |
| Date Added to Maude | 2018-05-31 |
| 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 | BRENDAN CASEY, PH.D. |
| Manufacturer Street | BUILDING 275 5W 06 |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517374488 |
| 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 | 2018-05-31 |
| Model Number | N/A |
| Catalog Number | CFJ1-270 |
| Operator | NURSE |
| 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 | 2018-05-31 |