MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-03 for 3M? CUROS? DISINFECTING CAP FOR NEEDLELESS CONNECTORS N/A CFF1-270R manufactured by 3m Health Care.
[144153097]
A customer reported that a curos? Disinfecting cap was attached directly to a hickman line and mw 2110898-2019-00071 was submitted for that report. The customer reported during their investigation of that report, it was found that this occurred, an unspecified number of times, at other hospitals within their network. No individual information was provided regarding the additional reports. The customer reported re-education occurred at each hospital. Mw 2110898-2019-00072 was submitted for this additional report. Both the product packaging and the instructions for use (ifu) for 3m? Curos? Disinfecting cap for needleless connectors instruct that the product is only to be used on needleless connectors. Primary packaging: in multiple locations on the primary package, the product name and descriptor indicates the product is to be used with needless connectors. The generic descriptor "disinfecting cap for needless connectors" is translated in 27 languages. The packaging also includes the "warning, see ifu" symbol, which should direct the user to the ifu for full warning information. Ifu: information regarding the use with needless connectors can be found in multiple locations within the ifu, in bold lettering. Product name and generic descriptor 3m? Curos? Disinfecting cap for needleless connectors (translated into 27 languages). Intended use: the curos? Disinfecting cap is intended for use on needleless connectors only. Warning: to avoid potential for injury - use only on needleless connectors. Product packaging includes graphics instructing customers to apply the curos cap only to needleless connectors and not to apply the curos cap directly to a catheter hub. In addition, 3m provides training materials (including graphics) instructing customers to apply the curos cap only to needleless connectors and not to apply the curos cap directly to a catheter hub.
Patient Sequence No: 1, Text Type: N, H10
[144153098]
3m europe (eu) received a report from the eu authorities (mhra). A customer noted in a report that there was an unspecified number of incidents where a cff1-270r 3m? Curos? Disinfecting cap for needleless connector was attached directly to a hickman line at different hospitals within their network. The customer reported re-education was provided. No specific information was provided related to the individual incidents.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2019-00072 |
| MDR Report Key | 8577760 |
| Date Received | 2019-05-03 |
| Date of Report | 2019-05-03 |
| Date Mfgr Received | 2019-04-08 |
| Date Added to Maude | 2019-05-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DIANNE GIBBS |
| Manufacturer Street | 3M CENTER BUILDING 275-5W-06 2510 CONWAY AVE |
| 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 | 0 |
| Brand Name | 3M? CUROS? DISINFECTING CAP FOR NEEDLELESS CONNECTORS |
| Generic Name | CUROS DISINFECTING CAP FOR NEEDLELESS CONNECTORS |
| Product Code | LKB |
| Date Received | 2019-05-03 |
| Model Number | N/A |
| Catalog Number | CFF1-270R |
| Lot Number | UNK |
| 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 | 2019-05-03 |