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 2018-10-03 for 3M? CUROS JET? DISINFECTING CAP FOR NEEDLELESS CONNECTORS N/A UNKNOWN manufactured by 3m Health Care.
[122655016]
Product catalog and lot numbers were unknown. Without a catalog or lot number, expiration date, manufacture date and udi cannot be determined. Medical devices: baxter? Clearlink? Continu-flo? Solution system catalog number 2c8537 and baxter? Clearlink? Extension set/iv filter luer activated valve, catalog number 2h8603 were also reportedly used. (b)(4). 3m found this to be an intermittent incompatibility issue associated with the impact of system pressure on select needleless connector. The customer reported there were several other patients that had tpn infusing via the same setup (iv tubing, curos jet? Disinfecting caps) and those patients did not experience any leaking. The customer reported this patient experienced the exact same event two nights in a row. 2110898-21018-00088 was submitted for the leaking that occurred on (b)(6) 2018 and 2110898-2018-00089 was submitted for the leaking that occurred on (b)(6) 2018. 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. End of report
Patient Sequence No: 1, Text Type: N, H10
[122655017]
A nurse reported a patient had tpn infusing into a picc catheter via an infusion pump. Three cfj5-250 curos jet? Disinfecting caps were placed on the three needleless connectors (y-sites) of the iv tubing. The patient reportedly experienced leaking of tpn fluid from one of the needleless connector/curos jet? Disinfecting cap connections on two occasions. The patient reportedly noticed the leaking and notified his nurse immediately. The nurse reported a minimal amount of tpn had leaked and no patient harm occurred. The curos jet? Disinfecting caps were removed for the remainder of the tpn infusion.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2018-00089 |
| MDR Report Key | 7930409 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-03 |
| Date of Report | 2018-10-03 |
| Date of Event | 2018-09-18 |
| Date Mfgr Received | 2018-09-18 |
| Date Added to Maude | 2018-10-03 |
| 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 |
| 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 | 2018-10-03 |
| Model Number | N/A |
| Catalog Number | UNKNOWN |
| 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 | 2018-10-03 |