MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-03 for 03-4038A manufactured by Cardinal Health.
[96228000]
Patient Sequence No: 1, Text Type: N, H10
[96228001]
Patient connected to elastomeric pump containing 5fu for continuous home infusion. Patient reported to the chemo infusion center around 11 am to have his fanny pack replaced as the zipper had broken. At that time, everything was working properly. Around 2pm the patient reported back at the infusion department because the tubing from the 5fu pump had become disconnected from the tubing on the huber needle. Upon examining the patient and the equipment, the clave connector had become loosened to the point it came disconnected from the huber needling tubing. Subsequently the patient had chemotherapy on his clothing. Because the vascular access was compromised, the huber needle was removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7159693 |
| MDR Report Key | 7159693 |
| Date Received | 2018-01-03 |
| Date of Report | 2017-12-19 |
| Date of Event | 2017-12-04 |
| Report Date | 2017-12-19 |
| Date Reported to FDA | 2017-12-19 |
| Date Reported to Mfgr | 2017-12-19 |
| Date Added to Maude | 2018-01-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | PORT INTRODUCER KIT |
| Product Code | OKE |
| Date Received | 2018-01-03 |
| Catalog Number | 03-4038A |
| Lot Number | 435984 |
| Device Expiration Date | 2019-09-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1320 DON HASKINS SUITE A EL PASO TX 79936 US 79936 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-03 |