MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-06 for PORT INTRODUCER KIT manufactured by Cardinal Health.
[99127297]
Patient Sequence No: 1, Text Type: N, H10
[99127298]
Patient in for cadd disconnect, stating at 4 a. M. When he got up to use the br he felt like his shirt was wet and noticed that the tubing for port access to the chemo ball was broken and blood was coming out of tubing proximal to port site. He states that he had to cut the tubing to get the clamp to stop the blood from coming out of the port. Patent states the ball was flat at this time and a very small amount of chemo was spilled. Patient states that they used the spill kit to clean up the spill. Patient states that he went to the er to be evaluated. The er left the port needle in place and patient came to unit to be de accessed. Port needle taken out due to no place for it to be accessed and flushed. Patient then re accessed and flushed per protocol with no difficulties. Patient instructed to bag up his clothing from the spill until rn could further investigate what appropriate action to take with the clothing. Md made aware, with no new orders at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7244264 |
| MDR Report Key | 7244264 |
| Date Received | 2018-02-06 |
| Date of Report | 2018-01-17 |
| Date of Event | 2017-11-24 |
| Report Date | 2018-01-17 |
| Date Reported to FDA | 2018-01-17 |
| Date Reported to Mfgr | 2018-01-17 |
| Date Added to Maude | 2018-02-06 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | PORT INTRODUCER KIT |
| Product Code | OKE |
| Date Received | 2018-02-06 |
| ID Number | UNK |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 785 FORT MILL HWY. FORT MILL SC 29707 US 29707 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-06 |